Clinical Research Coordinator II

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The responsibilities may vary according to projects, but include the following:

• Oversees the day-to-day of trials under the supervision of the PI, working towards independent execution of clinical trials
• Utilizes MGB systems to screen for potential participants, track participant lifecycle in the trial, and collect and track data
• Maintains study regulatory binder, including screening and enrollment logs
• Acts as point of contact for study participants, including email and phone conversations to recruit and answer questions about the trial
• Organizes and manages study data and samples in -80 freezers; wet lab work will be included as part of sample processing (use of pipettes, centrifuges, etc.)
• Manages all Institutional Review Board (IRB) documentation accurately. Drafts and submits applications to the IRB, including initial submissions, amendments, and continuing review
• Prepares documents and study binders for FDA audits (if needed)
• Links research activities related to study protocols to patients in EPIC, including ordering study medications and scheduling research study visits
• Reviews medical charts to assess eligibility for studies
• Maintains a good understanding of the study protocols and study start-up/closeout process
• Orients and trains junior team members on the study protocols as appropriate
• Maintenance of trial IRB and regulatory documentation
• Manages participant payment system and tracking
• Acting as liaison with internal and external collaborators and sponsors to move trials forward.
• Managing research data, biological samples, and supporting other research project operations as needed
• Conduct blood draws, and collect saliva and other human samples as required by the protocol (training provided)
• Coordinates and conducts research study visits, including phlebotomy and post-visit sample processing
• Occasionally collect human samples through home study visits

QUALIFICATIONS:

Applicants should possess:

• High degree of computer literacy including Microsoft Excel, Word, PowerPoint, and Outlook programs; ability to learn new software (Epic, REDCap, Workday etc.)
• Strong interpersonal and communication skills, including the ability to interact with patients and study subjects.
• Basic laboratory techniques and methods
• Excellent attention to detail.
• Phlebotomy training (or willingness to become trained in phlebotomy)
• Capability to work well independently and within a multi-disciplinary team.
• Ability to balance and prioritize multiple dynamic projects and commitments.
• Willingness to commit to at least two years in the position is preferred.

EDUCATION:

Bachelor's degree required. MS or MPH a plus but not required.

EXPERIENCE:

Minimum of 1 year of Clinical Research experience is required. Past experience in laboratory skills, and patient facing experience is strongly encouraged. Some familiarity with medical terminology is needed.