Clinical Research/Regulatory Coordinator
- Location: Boston, MA
- Posted: May 22, 2019
Responsible for receiving and triaging requests for clinical research guidance/assistance from Department of Surgery faculty, fellows, and residents; preparing IRB regulatory documents and ensuring clinical research in the Departments portfolio is compliant with federal, state and institutional regulations and policies; participating in the development and implementation of clinical research studies; supervising, planning, and prioritizing the activities of Clinical Research Assistants.
1. Works collaboratively with the FIRST Program Associate Director to triage online submissions for clinical research guidance/assistance within the Department of Surgery.
2. Meets with Surgery faculty, fellows, and residents to assess how best the FIRST Program can help them to conduct their research projects.
3. Prepares and executes regulatory documents for BIDMC IRB, including working with principal investigators and/or research staff to submit protocols, amendments, notices, suspensions and terminations to the IRB for review and approval. Oversees and organizes regulatory compliance for the Surgery clinical research portfolio.
4. Participates in hiring and training Clinical Research Assistants. Monitors performance of staff. Contributes to annual performance evaluations of staff.
5. May interact with patients prior to entering a study and throughout a study. May discuss and obtain informed consent with patients. May assess potential patients' eligibility for inclusion in a particular study based on the nature of the study. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with clinical research nurse and/or principal investigator. May enroll patients into clinical trials or other studies.
6. Knowledge of human subjects regulations and experience in preparing and submitting documents for Institutional Review Board (IRB) review and approval.
7. Ability to work with multiple PIs and on multiple projects simultaneously.
Required Qualifications:Bachelor's degree required.
1-3 years related work experience required.
3. Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Competencies:Decision Making: Ability to make decisions that are guided by general instructions and practices requiring some interpretation. May make recommendations for solving problems of moderate complexity and importance.
Problem Solving: Ability to address problems that are varied, requiring analysis or interpretation of the situation using direct observation, knowledge and skills based on general precedents.
Independence of Action: Ability to follow precedents and procedures. May set priorities and organize work within general guidelines. Seeks assistance when confronted with difficult and/or unpredictable situations. Work progress is monitored by supervisor/manager.
Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.
Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.
Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.
Team Work: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.
Customer Service: Ability to demonstrate a positive attitude and respond to requests in a timely and respectful manner.
Physical Nature of the Job:
Sedentary work: Exerting up to 10 pounds of force occasionally in carrying, lifting, pushing, pulling objects. Sitting most of the time, with walking and standing required only occasionally