The Clinical Research Coordinator II works within the clinical research program and support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DF/HCC Clinical Trials Office and/or Partners HealthCare Institutional Review Board (IRB). The CRC II will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Ensures timely collection of protocol related samples including shipment to outside entities as required. Maintains regulatory binders and ensures study compliance with all local, state, federal, and IRB requirements. May be responsible for IRB protocol submissions (amendments, continuing reviews, and protocols). This individual may also screen patients for protocol eligibility, obtain informed consent, and register study participants to clinical trials.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Oversight of the clinical trials start-up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.

2. Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing and archiving of study records, and resolution of data queries.

3. Prepare and or complete regulatory related reports and IRB submissions. Maintain and organize study regulatory binders, enter all required study data on an ongoing basis.

4. Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.

5. Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.

6. Coordination and management of clinical trials, including communication with Sponsors and regulatory authorities.

7. Close-out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.

8. Interact with study participants as directed/required by the protocol and/or study team.

9. Interact with clinical services to coordinate patient care on protocol

10. May be responsible for tissue sample work.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• BS OR BA
• At least one year of work experience in a research setting. Sound independent judgment and competence in research methodologies.
• Ability to work independently and as a team member
• High degree of computer literacy
• Analytical skills and ability to resolve technical problems
• Ability to interpret acceptability of data results
• Working knowledge of data management program.
• May assist with the training and orientation of new staff members.

BWH is an Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.