Clinical Research Coordinator II - TraCR

Responsibilities

• Assists human subjects’ research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the NMRC CTC in conjunction with senior staff.
• Prepares and submits regulatory documents, including scientific and institutional review board submissions.
• Recruits and screens new subjects for participation in clinical research studies occurring in the NMRC CTC.
• Reviews new subjects records and screens subjects for eligibility in participation of research protocol(s).
• Interviews subjects for protocols and collects and analyzes appropriate data for recruitment purposes, determine subject commitment and obtains informed consent.
• Educates subjects about the research protocol, their roles in the protocols, and any other vital information.
• Maintains status reports on all subjects as appropriate.
• Acts as a liaison between subjects and clinicians and serves as a resource for the subjects.
• Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads.
• Monitors, documents, and reports adverse events and safety concerns in accordance with regulatory and sponsor requirements.
• Maintains status reports on all subjects as appropriate.
• Schedules subjects for appointments and visits.
• Trains and mentors junior research staff as needed.
• Travels from their assigned workplace to support protocols at other sites as needed.

Qualifications

• Education and Experience: Bachelor's Degree in Life Sciences or a related field required. Minimum of 3-5 years experience required.
• Required Knowledge, Skills And Abilities: Knowledge of federal and local regulations and policies pertinent to research involving human subjects, to include regulatory submissions. Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications. Ability to work independently and as part of a team in a fast-paced environment. Excellent interpersonal and computer skills, including experience with MS Office products (MS Outlook, MS Excel, MS Word, MS Teams) and Adobe Professional. Excellent attention to detail. Ability to communicate effectively and to work with individuals of all levels.
• Physical Capabilities: Lifting: Requires lifting materials up to 25 lbs. Ability to stand or sit at a computer for prolonged periods.