The Brigham and Women's Hospital Division of Maternal-Fetal Medicine in the Department of Obstetrics and Gynecology is seeking a highly motivated and experienced individual for a Clinical Research Coordinator (CRC) position to assist with ongoing and future clinical research studies.
The CRC I must be able to multi-task in a dynamic clinical research setting. This position works closely with the study team, including study physicians, nurses, and administration, and involves significant patient contact. The ability to work well in a team is a must. The flexibility to work independently is also necessary. This is the ideal position for someone looking to work with a dedicated group of people to advance studies at the intersection of obstetrics and cardiology. The CRC I will gain invaluable experience in high-risk obstetrics, cardiology, and primary care in an academic clinical research setting.
This position is ideal for someone interested in pursuing graduate studies or a career in the fields of medicine, public health, or clinical research. It involves patient interaction as a member of a clinical research team. Administrative responsibilities are also required of the individual who fills this role.
PRINCIPAL DUTIES AND RESPONSIBILITIES: Indicate key areas of responsibility, major job duties, special projects and key objectives for this position. These items should be evaluated throughout the year and included in the written annual evaluation.
The Clinical Research Coordinator I has the following duties and responsibilities:
- Manages studies under the supervision of the PI, including data collection, entry, and accuracy; Institutional Review Board maintenance; and patient interaction with study participants.
- Coordinates aspects of participant research study visits including scheduling, organizing documents, communicating and documenting informed consent, data collection and management, coordinating and scheduling follow-up visits.
- Maintains research data, patient files, and study databases
- Completes and maintains study screening logs, Institutional Review Board (IRB) documentation, regulatory files, source documentation, and case report forms.
- Links research activities related to study protocols to patients in EPIC (electronic health record)
- May be required to perform clinical tests such as phlebotomy, ECGs, vital signs, etc.
- Process blood samples; labels and ships specimens in compliance with regulatory and sponsor standards. Coordinate sample management with local biorepositories and third-party vendors.
- Monitors and manage study funds; prepares invoices
- Acts as liaison between wet lab research teams, Sponsors, CROs, and CRAs for research studies.
- Acts as a liaison between clinical and wet lab research teams
- Organizes and manages study data and samples in -80 freezers; some wet lab work may be included (use of pipettes, centrifuges, etc.)
- Follows research subjects per study protocols
- Acts as study resource for patients and families
- Submits IRB documentation. Drafts and submits applications to the IRB, including initial submissions, amendments, and continuing review.
- Prepares documents and study binders for FDA audits (if needed)
- Maintains study invoicing and budgets
- Orients and trains junior team members on the study protocols as appropriate
- Maintains a good understanding of the study protocols and study start-up/closeout process
- Assists with other research-related administrative tasks as needed.
- Manage subject recruitment to research, including pre-screening and follow up calls.
- Schedule patients for study visits, provide reminder calls prior to visits
- Conduct study visits, including informed consent and clinical testing
- Obtain, compile, and enter demographic, clinical, and necessary study data into study electronic data capture system
FISCAL RESPONSIBILITY (if applicable): Indicate financial "scope" information, i.e.: size of budget, volume, revenue, etc.; Indicate total physician/non-physician FTE scope. May monitor and manage study funds. Responsible for preparing invoices and for directing, verifying, and correcting patient care charges as appropriate. These may be industry sponsor funds or foundation or NIH grants.Qualifications
The Clinical Research Coordinator I should have the following skills and competencies:
- High degree of computer literacy including Microsoft Excel, Word, PowerPoint, and Outlook programs; ability to learn new software (Epic, REDCap, PeopleSoft, etc.)
- Ability to work independently and as a team member
- Analytical skills and ability to resolve technical problems
- Ability to multi-task and prioritize responsibilities
- Basic laboratory techniques and methods
- Excellent patient communication skills
- Willingness to become trained in phlebotomy
- Exceptional organizational skills and the flexibility to handle multiple tasks and deadline pressures
- Any coding or computational science experience is a plus, but not required
- Training in CITI and GCP preferred. (Both are required during onboarding and can be provided by BWH during first full week of employment.)
Minimum education required BA/BS (preferred in science related field).
EXPERIENCE: Previous experience in clinical research is a plus. Past experience in coursework involving laboratory skills, as well as past experience in a hospital setting, is strongly encouraged. Some familiarity with medical terminology is needed. Past patient-facing clinical experience is strongly encouraged.
Prior experience in clinical research, including, coordinating industry sponsored investigational new drugs is a plus but not required.EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, ancestry, age, veteran status, disability unrelated to job requirements, genetic information, military service, or other protected status.