Clinical Research Associate/Clinical Research Coordinator I (Biopsy Project)

Education
Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience
Clinical Research or compliance experience 1-2 years preferred

Knowledge, Skills and Abilities
- Ability to work independently and as a team member.
- Analytical skills and ability to resolve problems.
- Ability to interpret acceptability of data results.
- Careful attention to detail.
- Good organizational and communication skills.
- Working knowledge of clinical research protocols.

The Translational Clinical Research Associate/Clinical Research Coordinator works under general supervision to consent and enroll eligible patients to clinical translational research protocols and manage all aspects of data collection and requests. In particular, the CRA/CRC I will work on specimen collection studies. The Translational CRC/CRA will work closely with multiple providers to support their translational research projects, including the Breast Biopsy Project. 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. This is an on-site/hybrid position. Duties will be performed primarily on-site in ambulatory/clinical office setting. Components of the data/regulatory role may allow for remote work. The position involves direct patient contact daily.

All duties will be performed under general supervision by the Clinical Research Manager.

The following clinical duties will be performed:

* Interfacing in a professional manner with a diverse team of physicians, clinical research assistants, research nurses, pathologists and patients
* Coordinating the collection and processing of tissue samples and blood samples from patients, which can include being in the biopsy procedure room
* Consent patients to translational research studies (minimal risk specimen collection studies)
* Explain study protocol to patients and obtain informed consent
* Screen and follow patients relevant to specific projects/studies
* Assist clinical team in screening potential patients for study participation and coordinate with the clinical team to consent patients and collect tissue
* Schedule all protocol required tests and procedures
* Consent patients to specimen collection protocols
* Coordinate patient appointments with physicians, nurses, and all test areas
* 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 blood and tissue samples, specifically coordinating with a Lab
* 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)

The following data management responsibilities will be performed:

* Collecting detailed clinical and treatment information on patients who are undergoing screening for breast cancer, genetic testing, receiving treatments for cancer, or are enrolled in a research study
* Maintaining an updated and organized database of patients
* Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria
* Enroll/register patients
* 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.
* 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
* Facilitate the request and shipment of samples
* Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies
* Produce reports on the status of projects
* Assist in abstracts, presentations, and manuscripts

The following regulatory duties may be performed:

* Assist with new study submission
* Assist with updates and/or changes to current studies
* 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
* Maintain documentation of correspondence with the IRB, investigators, and the lab throughout the clinical trial process
* Collect, complete, and submit essential regulatory documents to various regulatory entities
* Ensure appropriate documentation of delegation and training for all study staff members
* Maintain screening and enrollment documentation
* Prepare monthly enrollment and data summary for study team