Clinquest - Your Partner From Bench to Market

Career Opportunities

Clinquest is a company of experienced, innovative and creative professionals who enjoy working on the cutting-edge of the healthcare product development industry. Our team provides high-level strategic consulting to biotechnology, pharmaceutical, medical device and medical diagnostics companies.

At Clinquest, we know that our success rests in the minds of our highly knowledgeable and experienced professionals and, therefore, we are always interested in hiring the best, brightest and most qualified individuals into our group practices.

If you're interested in developing breakthrough healthcare products that will improve treatments for various disease settings, we want to hear from you.

CLINQUEST DOES NOT ACCEPT UNSOLICITED RESUMES OR APPLICATIONS

Current Openings

CLINQUEST is Hiring Clinical Research and Drug Safety Consultants

Clinquest is a small but growing biotech consulting company. We specialize in providing product development advice and services to biotech and pharmaceutical companies. We are looking for experienced clinical research professionals who want to make the transition to consultant and for medical personnel who want to make the transition into the pharmaceutical industry.

As a Clinquest clinical research consultant, you will be responsible for developing and implementing Phase I and II clinical trials. You will work in a team environment with other creative, dedicated professionals where you will have significant input into the design and management of our clients’ studies.

Because we are a small group, we are looking for very dedicated professionals at all levels of experience. Our projects are challenging and require creativity and intelligence. Within Clinquest, you will help build internal systems used to support our growth. Clinquest's corporate management philosophy is meant to nurture a dynamic and entrepreneurial atmosphere.

Clinquest has the following job positions available:

Clinical Trial Manager II

The Clinical Trial Manager (CTM) is responsible for the management and conduct of select clinical trials. The CTM will provide operational support for clinical trials in compliance with ICH/GCP and FDA guidelines and the delivery of high quality data in support of clinical research objectives.

Responsibilities:

Develop and manage study timelines and budgets including resource planning to ensure that projects are delivered on time, within budget, and according to requirements and client expectations
Assist with the development of relevant study-specific documents including site tools, monitoring worksheets and project management tracking tools
Manages all daily project management activities, including project timeline and budget development, team leadership, sponsor interactions, vendor management, project team performance and resource management
Responsible for study start up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, participates in Investigator Meeting and monitors timely enrollment
Manage financial aspects of study including budgets with cost accounting, change orders, investigator payments and study-related invoices
Communicates and manages expectations with Sponsor and Executive Management on key project status, impediments to progress and generation of progress reports in a timely basis
Conducts regular team meetings with sponsors and associated vendors Assists in determining monitor schedules and internal study staff resources Initiate and maintain communication with investigational review boards and data safety monitoring boards regarding all ongoing clinical trial information (as applicable)
Supervises and mentors team members and ensures team members understand project objectives, specifications, deliverables, timelines and tasks
Oversee the collection of study and site-specific regulatory documentation necessary for initial drug shipment and filing to the IND
Confirm investigative sites' adherence to pertinent regulations with regards to protection of subjects' rights and safety through review of monitoring reports, QA-GCP audits and communications with CRAs, and/or investigative site personnel
Prepare meeting agendas (and minutes) include tracking action items, coordinating team activities and disseminating project information
Performs risk assessment of project objectives and escalates to management if there is a significant impact on time, cost or deliverables

Qualifications:

Minimum of 3 - 5 years experience in clinical research BS in life sciences or health-care related discipline; Advanced degree preferred
In depth and working knowledge of GCPs, FDA regulations, ICH guidelines and the Drug Development process is essential
Proficient in Microsoft Office suite and medical/scientific writing skills
Ability to simultaneously manage multiple clinical trials, attention to detail and be committed to high quality deliverables
Excellent communication, organizational, interpersonal and leadership skills and the ability to work in a team environment are required
Must be willing to travel (up to 25%), if necessary

Senior Clinical Trial Associate

Work closely with Project Managers, CRAs and other members of the clinical team to ensure effective and efficient management of various aspects of Phase I-IV clinical trials. Responsible for multiple projects simultaneously. Conduct various project management/data management responsibilities on a more independent basis. Participate in the training and mentoring of Clinical Trial Associate I/II personnel. Requires minimal supervision.

Responsibilities will include:

Ensure set up, maintenance and overall quality of TMF for assigned clinical trial(s)
Collect, review, track and update project/regulatory documents as required
Perform central clinical trial tracking and progress reporting (including site selection, site enrollment, study documentation collection, site activation, patient enrollment, CRF status, budgets and contracts, etc.)
Maintain open communications with Project Manager as required for study implementation, problem resolution, vendor management
Perform in-house site support activities, researching and responding to various site inquiries (study materials, protocol, study documents, CRF conventions, queries, payments, etc.), appropriately documenting these interactions
Perform and/or facilitate a diverse set of activities through all phases of projects, from project preparation/start-up through closeout (including elements of project initiation, study document preparation/management, site monitoring/management, and clinical data management)
Participate in the development and maintenance of project timelines/Gantt charts
Act as site liaison, providing primary or secondary point of contact throughout project
Participate in the development of study specific project plan, monitoring/data conventions, tracking forms, study manual and other study related materials
Partner with QA team in the conduct of routine audits of TMF and/or study site files
Participate in site monitoring/co-monitoring activities
Independently perform various data management related activities (Plan and facilitate data collection, retrieval and processing to ensure data cleaning and transfers are scheduled to meet interim/final analysis time points; review data management documentation (DVP, DMP, CRFs, aCRFs, monitoring/data conventions, CCGs, etc.)
Participate in data review, query review, listing review, coding, etc.
Assist in training and mentoring of junior CTAs
Perform other duties and assignments as requested for the overall performance of the department and the company
Assist with other projects and department initiatives as necessary to meet the needs of the business
Travel may be required (<20%)

Position Qualifications:

Bachelor’s Degree in science/health related field strongly preferred
5+ years of experience as a CTA or Clinical Research Coordinator / Clinical Research Coordinator Supervisor in an academic or private practice setting. Experience may be determined on the basis of an equivalent combination of education, training, and experience that provides the individual with a strong background and working knowledge of the clinical research process.
Strong understanding of the clinical trial process as well ICH GCP and regulatory requirements
Knowledge of medical terminology
Clinical data management experience preferred

Other skills/Abilities :

Able to work to timelines and do so efficiently under pressure
Ability to manage multiple and varied tasks with enthusiasm and attention to detail
A high degree of time and priority management
Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
Strong organizational skills; excellent oral/written communication skills; detail oriented
Ability to thrive in a fast paced, start-up environment
Self-motivated, shows initiative, is proactive and able to work independently as well as in a team
Strong critical thinking, forward thinking and problem solving skills
Willingness to work with multiple supervisors in a matrix environment
Experience in Microsoft Office products

Clinical Research Associate II

Works on one or more projects of moderate complexity with supervision and mentoring of a senior CRA or manager. Liaison between sponsor and sites to insure investigational site compliance with clinical protocols, SOPs, GCP, ICH and FDA guidelines and regulations. Responsible for planning and implementing all activities required to conduct and monitor moderately complex clinical trials. Generates study related documents and forms as needed.

Responsibilities will include:

Ability to simultaneously monitor one or more moderately complex protocols inclusive of review of source documents, case report forms, regulatory documents, informed consents, investigational product accountability, clinical supply accountability and AE/SAE reporting
Conducts site qualification, initiation, interim and close-out visits independently
Ability to assess and prioritize site workload on one or multiple protocols
Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment issues, as necessary
Ensures the completion and accuracy of project-specific tracking requirements including patient enrollment, regulatory documents and data clarification requests
Develops monitoring reference manuals and monitor study tools as requested
Preparation of all monitoring reports and site correspondence
Keeps study team and project manager fully apprised of site and study status
Travel 50-60%.

Position Qualifications:

Minimum of a bachelor’s level degree in science/health related field is preferred (RN, pharmacist, medical technologist)
MS degree strongly preferred
Two to five years experience in clinical/industry research
Minimum of two years of clinical monitoring experience required
CRA certified or eligible for certification

Other skills/Abilities :

Good verbal and written communication skills
Excellent interpersonal and organizational skills
Must possess demonstrated analytical, problem solving and planning skills

Pharmacovigilance Coordinator

Ensures that all adverse event reports received by Clinquest, Inc are assessed and triaged to the appropriate team members for team notification and data processing. Initiates the adverse event report flow process within the adverse event database. Responsible for file assembly and maintenance of case files.

Responsibilities include:

Receive and triage adverse event reports
Perform duplicate report checks and initial entry
Track case reports through review processes
Handle high volume and time sensitive paperwork
Performs other duties as assigned

Position Qualifications:

Bachelor’s degree or relevant experience in the health care industry
Excellent communication skills
Excellent computer skills including Microsoft Outlook, Word, and Excel and database data entry capabilities

Other Skills/Abilities:

Proficiency in standard word processing, spreadsheet, and database packages

Pharmacovigilance Associate I

To ensure that all adverse event reports received by Clinquest, Inc are assessed for reportability. Responsible for sending team notifications of receipt of adverse events. Performs data entry and forwards reports for appropriate review and sign-off. Assesses reports for follow-up needs and performs appropriate due diligence.

Responsibilities will include:

Assess reports for serious criteria according to applicable SOP, ICH, and Federal Regulations
Perform data entry and narrative writing for case reports
Prepare case reports for medical review
Assess case reports for due diligence
Communicate with reporters regarding data discrepancies
Ensures compliance with domestic and international regulatory requirements
Prepare ad-hoc data listings

Position Qualifications:

Bachelor’s degree (health care related field preferred)
0-2 years experience in drug safety or related field
Excellent written and verbal communication skills
Detail-oriented with excellent organizational skills

Other Skills/Abilities:

Proficiency in standard word processing, spreadsheet and database packages
Knowledge of medical terminology

Pharmacovigilance Associate II

To ensure that all adverse event reports received by Clinquest, Inc are assessed for reportability and critically evaluate safety data and alert management as necessary. Familiar with standard Pharmacovigilance case processing and database packages. Participates in cross functional project teams. Participates in the preparation of regulatory reports including IND and PSURs.

Responsibilities will include:

Evaluate reports for serious criteria according to SOP, ICH, and Federal Regulations
Process reports of adverse events including preparation for review and follow-up
Communicate with reporters regarding data discrepancies
Ensures compliance with domestic and international regulatory requirements
Prepares ad-hoc data listings as necessary for internal and regulatory reports
Participates in cross functional teams
Performs data reconciliation activities
Trains junior team members

Position Qualifications:

Bachelor’s degree (health care related field preferred)
1-3 years experience (or demonstrated ability) in drug safety or related field
Knowledge of general scope of work of junior positions
Excellent written and verbal communication skills
Detail-oriented with excellent organizational skills Other Skills/Abilities
Proficiency in standard word processing, spreadsheet and database packages
Knowledge of medical terminology and coding dictionaries
Critical thinking and problem solving
Demonstrates leadership capacity

Please contact Pam Centilli-Raiche at...
Clinquest, Inc.
One Cabot Road
Hudson, MA 01749
978-568-8880
978-568-8206 fax




		Career Opportunities Clinquest is a company of experienced, innovative and creative professionals who enjoy working on the cutting-edge of the healthcare product development industry. Our team provides high-level strategic consulting to biotechnology, pharmaceutical, medical device and medical diagnostics companies. At Clinquest, we know that our success rests in the minds of our highly knowledgeable and experienced professionals and, therefore, we are always interested in hiring the best, brightest and most qualified individuals into our group practices. If you're interested in developing breakthrough healthcare products that will improve treatments for various disease settings, we want to hear from you. CLINQUEST DOES NOT ACCEPT UNSOLICITED RESUMES OR APPLICATIONS Current Openings CLINQUEST is Hiring Clinical Research and Drug Safety Consultants Clinquest is a small but growing biotech consulting company. We specialize in providing product development advice and services to biotech and pharmaceutical companies. We are looking for experienced clinical research professionals who want to make the transition to consultant and for medical personnel who want to make the transition into the pharmaceutical industry. As a Clinquest clinical research consultant, you will be responsible for developing and implementing Phase I and II clinical trials. You will work in a team environment with other creative, dedicated professionals where you will have significant input into the design and management of our clients’ studies. Because we are a small group, we are looking for very dedicated professionals at all levels of experience. Our projects are challenging and require creativity and intelligence. Within Clinquest, you will help build internal systems used to support our growth. Clinquest's corporate management philosophy is meant to nurture a dynamic and entrepreneurial atmosphere. Clinquest has the following job positions available: Clinical Trial Manager II The Clinical Trial Manager (CTM) is responsible for the management and conduct of select clinical trials. The CTM will provide operational support for clinical trials in compliance with ICH/GCP and FDA guidelines and the delivery of high quality data in support of clinical research objectives. Responsibilities: Develop and manage study timelines and budgets including resource planning to ensure that projects are delivered on time, within budget, and according to requirements and client expectations Assist with the development of relevant study-specific documents including site tools, monitoring worksheets and project management tracking tools Manages all daily project management activities, including project timeline and budget development, team leadership, sponsor interactions, vendor management, project team performance and resource management Responsible for study start up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, participates in Investigator Meeting and monitors timely enrollment Manage financial aspects of study including budgets with cost accounting, change orders, investigator payments and study-related invoices Communicates and manages expectations with Sponsor and Executive Management on key project status, impediments to progress and generation of progress reports in a timely basis Conducts regular team meetings with sponsors and associated vendors Assists in determining monitor schedules and internal study staff resources Initiate and maintain communication with investigational review boards and data safety monitoring boards regarding all ongoing clinical trial information (as applicable) Supervises and mentors team members and ensures team members understand project objectives, specifications, deliverables, timelines and tasks Oversee the collection of study and site-specific regulatory documentation necessary for initial drug shipment and filing to the IND Confirm investigative sites' adherence to pertinent regulations with regards to protection of subjects' rights and safety through review of monitoring reports, QA-GCP audits and communications with CRAs, and/or investigative site personnel Prepare meeting agendas (and minutes) include tracking action items, coordinating team activities and disseminating project information Performs risk assessment of project objectives and escalates to management if there is a significant impact on time, cost or deliverables Qualifications: Minimum of 3 - 5 years experience in clinical research BS in life sciences or health-care related discipline; Advanced degree preferred In depth and working knowledge of GCPs, FDA regulations, ICH guidelines and the Drug Development process is essential Proficient in Microsoft Office suite and medical/scientific writing skills Ability to simultaneously manage multiple clinical trials, attention to detail and be committed to high quality deliverables Excellent communication, organizational, interpersonal and leadership skills and the ability to work in a team environment are required Must be willing to travel (up to 25%), if necessary Senior Clinical Trial Associate Work closely with Project Managers, CRAs and other members of the clinical team to ensure effective and efficient management of various aspects of Phase I-IV clinical trials. Responsible for multiple projects simultaneously. Conduct various project management/data management responsibilities on a more independent basis. Participate in the training and mentoring of Clinical Trial Associate I/II personnel. Requires minimal supervision. Responsibilities will include: Ensure set up, maintenance and overall quality of TMF for assigned clinical trial(s) Collect, review, track and update project/regulatory documents as required Perform central clinical trial tracking and progress reporting (including site selection, site enrollment, study documentation collection, site activation, patient enrollment, CRF status, budgets and contracts, etc.) Maintain open communications with Project Manager as required for study implementation, problem resolution, vendor management Perform in-house site support activities, researching and responding to various site inquiries (study materials, protocol, study documents, CRF conventions, queries, payments, etc.), appropriately documenting these interactions Perform and/or facilitate a diverse set of activities through all phases of projects, from project preparation/start-up through closeout (including elements of project initiation, study document preparation/management, site monitoring/management, and clinical data management) Participate in the development and maintenance of project timelines/Gantt charts Act as site liaison, providing primary or secondary point of contact throughout project Participate in the development of study specific project plan, monitoring/data conventions, tracking forms, study manual and other study related materials Partner with QA team in the conduct of routine audits of TMF and/or study site files Participate in site monitoring/co-monitoring activities Independently perform various data management related activities (Plan and facilitate data collection, retrieval and processing to ensure data cleaning and transfers are scheduled to meet interim/final analysis time points; review data management documentation (DVP, DMP, CRFs, aCRFs, monitoring/data conventions, CCGs, etc.) Participate in data review, query review, listing review, coding, etc. Assist in training and mentoring of junior CTAs Perform other duties and assignments as requested for the overall performance of the department and the company Assist with other projects and department initiatives as necessary to meet the needs of the business Travel may be required (<20%) Position Qualifications: Bachelor’s Degree in science/health related field strongly preferred 5+ years of experience as a CTA or Clinical Research Coordinator / Clinical Research Coordinator Supervisor in an academic or private practice setting. Experience may be determined on the basis of an equivalent combination of education, training, and experience that provides the individual with a strong background and working knowledge of the clinical research process. Strong understanding of the clinical trial process as well ICH GCP and regulatory requirements Knowledge of medical terminology Clinical data management experience preferred Other skills/Abilities : Able to work to timelines and do so efficiently under pressure Ability to manage multiple and varied tasks with enthusiasm and attention to detail A high degree of time and priority management Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact Strong organizational skills; excellent oral/written communication skills; detail oriented Ability to thrive in a fast paced, start-up environment Self-motivated, shows initiative, is proactive and able to work independently as well as in a team Strong critical thinking, forward thinking and problem solving skills Willingness to work with multiple supervisors in a matrix environment Experience in Microsoft Office products Clinical Research Associate II Works on one or more projects of moderate complexity with supervision and mentoring of a senior CRA or manager. Liaison between sponsor and sites to insure investigational site compliance with clinical protocols, SOPs, GCP, ICH and FDA guidelines and regulations. Responsible for planning and implementing all activities required to conduct and monitor moderately complex clinical trials. Generates study related documents and forms as needed. Responsibilities will include: Ability to simultaneously monitor one or more moderately complex protocols inclusive of review of source documents, case report forms, regulatory documents, informed consents, investigational product accountability, clinical supply accountability and AE/SAE reporting Conducts site qualification, initiation, interim and close-out visits independently Ability to assess and prioritize site workload on one or multiple protocols Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment issues, as necessary Ensures the completion and accuracy of project-specific tracking requirements including patient enrollment, regulatory documents and data clarification requests Develops monitoring reference manuals and monitor study tools as requested Preparation of all monitoring reports and site correspondence Keeps study team and project manager fully apprised of site and study status Travel 50-60%. Position Qualifications: Minimum of a bachelor’s level degree in science/health related field is preferred (RN, pharmacist, medical technologist) MS degree strongly preferred Two to five years experience in clinical/industry research Minimum of two years of clinical monitoring experience required CRA certified or eligible for certification Other skills/Abilities : Good verbal and written communication skills Excellent interpersonal and organizational skills Must possess demonstrated analytical, problem solving and planning skills Pharmacovigilance Coordinator Ensures that all adverse event reports received by Clinquest, Inc are assessed and triaged to the appropriate team members for team notification and data processing. Initiates the adverse event report flow process within the adverse event database. Responsible for file assembly and maintenance of case files. Responsibilities include: Receive and triage adverse event reports Perform duplicate report checks and initial entry Track case reports through review processes Handle high volume and time sensitive paperwork Performs other duties as assigned Position Qualifications: Bachelor’s degree or relevant experience in the health care industry Excellent communication skills Excellent computer skills including Microsoft Outlook, Word, and Excel and database data entry capabilities Other Skills/Abilities: Proficiency in standard word processing, spreadsheet, and database packages Pharmacovigilance Associate I To ensure that all adverse event reports received by Clinquest, Inc are assessed for reportability. Responsible for sending team notifications of receipt of adverse events. Performs data entry and forwards reports for appropriate review and sign-off. Assesses reports for follow-up needs and performs appropriate due diligence. Responsibilities will include: Assess reports for serious criteria according to applicable SOP, ICH, and Federal Regulations Perform data entry and narrative writing for case reports Prepare case reports for medical review Assess case reports for due diligence Communicate with reporters regarding data discrepancies Ensures compliance with domestic and international regulatory requirements Prepare ad-hoc data listings Position Qualifications: Bachelor’s degree (health care related field preferred) 0-2 years experience in drug safety or related field Excellent written and verbal communication skills Detail-oriented with excellent organizational skills Other Skills/Abilities: Proficiency in standard word processing, spreadsheet and database packages Knowledge of medical terminology Pharmacovigilance Associate II To ensure that all adverse event reports received by Clinquest, Inc are assessed for reportability and critically evaluate safety data and alert management as necessary. Familiar with standard Pharmacovigilance case processing and database packages. Participates in cross functional project teams. Participates in the preparation of regulatory reports including IND and PSURs. Responsibilities will include: Evaluate reports for serious criteria according to SOP, ICH, and Federal Regulations Process reports of adverse events including preparation for review and follow-up Communicate with reporters regarding data discrepancies Ensures compliance with domestic and international regulatory requirements Prepares ad-hoc data listings as necessary for internal and regulatory reports Participates in cross functional teams Performs data reconciliation activities Trains junior team members Position Qualifications: Bachelor’s degree (health care related field preferred) 1-3 years experience (or demonstrated ability) in drug safety or related field Knowledge of general scope of work of junior positions Excellent written and verbal communication skills Detail-oriented with excellent organizational skills Other Skills/Abilities Proficiency in standard word processing, spreadsheet and database packages Knowledge of medical terminology and coding dictionaries Critical thinking and problem solving Demonstrates leadership capacity Please contact Pam Centilli-Raiche at... Clinquest, Inc. One Cabot Road Hudson, MA 01749 978-568-8880 978-568-8206 fax