Clinical Research Coordinator
Clinical Research Coordinator in the Department of Obstetrics and Gynecology
Job Summary: Responsible for managing/overseeing the recruiting, screening and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including assisting with the grant application process and monitoring expenses for all protocols. Supervisory duties including overseeing the progress of protocols; supervising, planning and prioritizing the work of the Clinical Research Assistants.
Essential Responsibilities:
- Participates in hiring and training Clinical Research Assistants. Monitors performance of staff. Contributes to annual performance evaluations of staff. Ensures that schedules, follow up and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems.
- Assists in the execution of new IRB applications and processes annual reviews for the IRB committees with regard to consents. May attend IRB meetings as required or address IRB questions regarding the protocols or consent forms. Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval.
- Interacts with patients prior to entering the study and throughout the entire treatment. Discusses and obtains informed consent with patients. Revises protocol consent form to comply with federal, state and IRB guidelines.
- Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. Checks all eligibility or ineligibility criteria with the patients' medical record. Verifies information with clinical research nurse and/or principal investigator. May enroll patients onto clinical trials.
- Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB. May interact with sponsors and/or pharmaceutical company representatives. May prepare reports for pharmaceutical company monitors as well as routine audits for the FDA, if applicable.
Required Qualifications:
- Bachelor's degree required. Bachelor's degree in scientific discipline preferred.
- 1-3 years related work experience required.
- Bachelors degree and two years experience in a medical setting and/or clinical research or a Master's Degree and one year experience.
- 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
EOE Statement
BIDMC is EOE M/F/VET/DISABILITY/GENDER IDENTITY/SEXUAL ORIENTATION
Vaccines
As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. BILH requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement