Clinical Research Coordinator II Neuroscience Clinical Trials

Job Summary

Working under the supervision of the Administrative Director of the CNCT and the Principal Investigator and following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; maintaining and updating data generated by the study, all IRB submissions such as application, amendments, annual reviews and adverse events, and communicating with national and international research collaborators.

Essential Functions (Key Roles & Responsibilities)

• Assists with clinical research studies as per study guidelines and protocols.
• Screen for eligibility, recruit and evaluate potential study patients.
• Per protocol instruction, conducts telephone interviews or schedules patients for in-person study visits and screening.
• May be required to perform clinical tests such as questionnaires, cognitive assessments, etc. if certified and as needed.
• Will work with colleagues in research labs to set up lab testing, shipping, etc.
• Responsible for collecting data and maintaining the patient information database for several studies. It may be required to input data.
• Maintains study subject records as a part of the record-keeping function.
• Prepares data for analysis and data entry.
• Interact with patients/subjects regarding the studies, including patient education, procedural instruction, and follow-up.
• Prepare materials to advertise studies.
• Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff.
• Will serve as a liaison between patient and physician. First point of contact for study communication.
• Advocate for patients to ensure a good experience while in your trial and assure compliance.
• Communicates with sponsor companies, CRAs, central labs, and testing facilities, both external and internal.
• Responsible for scheduling all research meetings with monitors or sponsors.
• Creates, distributes, and files all study documents per protocol and updates them as needed.
• Responsible for various study information or packets, i.e., schedules, directions, and reimbursements to study participants.
• Responsible for staff study training.
• Prepares and submits all IRB documents: applications, amendments, annual reviews, and serious adverse events.
• Oversees study budgets and patient reimbursements.
• Monitors and sets up any needed equipment.
• Maintains inventory and orders supplies when necessary.
• Maintains all study regulatory documents.
• All research administrative tasks.
• Performs other duties as assigned
• Complies with all policies and standards.

Qualifications

Education: Bachelor's Degree required. Can this role accept experience in lieu of a degree? Yes.

Experience: Related post-bachelor's degree research experience 1-2 years required.

Knowledge, Skills and Abilities

• Ability to work more independently and as a team member.
• Computer literacy, analytical skills, and ability to resolve technical problems.
• Ability to interpret the acceptability of data results.
• Working knowledge of data management programs.