Clinical Research Associate/Coordinator--Cancer Center Protocol Office
2 weeks ago
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Associate/Clinical Research Coordinator. The Cancer Center Protocol Office is a centralized research office that supports clinical researchers in all disciplines within the Cancer Center. Our office promotes and facilitates clinical research by providing comprehensive services to physicians conducting clinical trials while ensuring compliance with all regulatory requirements.
The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The CRA/CRC I will be trained on the institutional and federal regulations governing clinical research. The position involves a combination of data abstraction and entry, regulatory management, and patient coordination. The position involves direct patient contact.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
All duties will be performed under general supervision by the Clinical Research Manager.
The following clinical duties will be performed:
* Assist clinical team in screening potential patients for study participation
* Schedule all protocol required tests and procedures
* Coordinate patient appointments with physicians, nurses, and all test areas
* Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers
* Prepare pre-visit communication for providers to ensure required assessments are completed and documented
* Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation
* Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition
* Coordinate, obtain, process, and ship protocol required tissue samples
* Ensure collection and processing (e.g. spin/separate/freeze) of all required correlative research blood samples with the coordination of the MGH Sample Processing Lab (SPL)
* Obtain vital signs and perform EKGs as required for individual studies
* Administer quality of life assessments as required for individual studies
The following data management responsibilities will be performed:
* Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
* Enroll patients as required by the study sponsor and internal enrollment monitor team
* Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance
* Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements.
* Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations
* Maintain research charts and/or electronic files for all enrolled patients
* Ensure adequate source documentation is in place for all data reported
* Resolve data queries issued by the sponsor
* Obtain protocol clarifications from the study sponsor and communicate information to the research team
* Schedule and prepare for monitoring visits with sponsors
* Facilitate the request and shipment of archival pathology samples
* Organize and prepare for internal and external audits
* Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
The following regulatory duties may be performed:
* Maintain and organize study specific regulatory binders
* Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
* Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
* Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
* Submit Data and Safety Monitoring Reports
* Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
* Collect, complete, and submit essential regulatory documents to various regulatory entities
* Participate in monitoring visits and file all monitoring visit correspondence
* Ensure appropriate documentation of delegation and training for all study staff members
* Maintain screening and enrollment logs
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
* Careful attention to detail
* Good organizational skills
* Ability to follow directions
* Good communication skills
* Computer literacy
* Working knowledge of clinical research protocols
* Ability to demonstrate respect and professionalism for subjects rights and individual needs
EDUCATION:
* BA/BS degree required
EXPERIENCE:
* None
SUPERVISORY RESPONSIBILITY:
* None
WORKING CONDITIONS:
* Duties will be performed primarily on-site in ambulatory/clinical office setting
* Components of the data/regulatory role may allow for remote work
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