The Senior Clinical Research Coordinator (Sr. CRC) supports, facilitates and coordinates clinical psychiatric research activities. Working with the research manager, coordinates the implementation and maintenance of human clinical trials at WMed and also helps train junior staff. Coordinates and conducts the clinical research including the planning, implementation and follow through for industry-sponsored clinical trials, government-funded clinical research and investigator-initiated clinical research drug/device studies conducted by the Principal Investigator (PI).

• Responsible as the primary point of contact for study participants and sponsors on approximately 3-4 human clinical trials in partnership with leading academic, government and industry leaders locally and nationally.
• Provide direct supervision of other study coordinators, clinical trial assistants, and regulatory documents specialists assisting with ongoing and upcoming psychiatry clinical trials.
• Develop and maintain program training of research assistants and coordinate procedures for psychiatry research.
• Oversees, monitors, and maintains study systems for effective participant and data flow for studies.
• Supervise all aspects of research visits including recruitment, eligibility, informed consent, tracking, follow-up, and chart reviews and collaborate with other members of the team as needed for the study.
• Participate in internal study audits of clinical studies as well as external audits by federal agencies and pharmaceutical companies.
• Represent psychiatry research at internal and external academic meetings and community events. Act as a liaison to collaborators to discuss new protocols or projects that could be implemented.
• Trains and mentors research assistants, new investigators, students, residents and fellows on regulatory processes related to clinical research activities.
• Supports residency program and medical students by acting as a research subject matter expert and for psychiatry research projects.
• Coordinates educational activities related to study needs for study staff, investigator team and patient care staff.
• Serves as instructor and mentor for quality and education activities.
• Provide guidance and training to Investigators and study staff regarding protocol requirements.
• Provides leadership for direct patient care interaction.
• Leads and mentors others in sponsor correspondence, monitoring and study meetings.
• Assists in the preparation/submission of grant proposals/applications. Liaises with IRB, funding agencies and external collaborators.
• Works with Investigator to prepare dissemination materials (e.g. manuscripts, abstracts, presentations, and posters for meeting.
• Provides input on, design of study forms/SOPs, participant information materials, recruitment of study participants, data collection, creation of databases, and ordering equipment.
• Inventories, tracks expiration dates, monitors storage temperature excursions and performs study drug and lab kit accountability.
• Ability to perform phlebotomy, collect vital signs and perform ECGs is desired but not required. A willingness to learn these skills is required.
• Creates detailed Source Documents and quality control checks of collected data.
• Will mentor and train junior Clinical Research Coordinators, as directed.
• Assist in coordinating communication between research funders and all relevant departments at WMed and affiliates.
• Initiates and maintains all IRB protocols and activities, as applicable.
• Assists in the creation/management of psychiatry clinical website.
• Availability to work on weekends and evenings to complete time sensitive projects.
• Acquires knowledge for new technology and policy/procedure revisions.
• All other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required. 

EDUCATION AND/OR EXPERIENCE: 

• Five plus years prior experience in clinical trial research is required.
• Bachelor’s degree in psychology, counseling, social work, nursing or related field required Master’s degree preferred.
• GCP, HSP and IATA training is desired. or ability to obtain withing 30 days of hire.
• Specific experience in schizophrenia research or neuropsychological testing is desired, but not required.
• Strong experience collecting data for research (e.g. recruitment, conducting interviews, extracting medical records and data analysis) is desired.
• Experience with performing, or ability to learn to perform, phlebotomy, ECG and obtaining vital signs, preferred.
• Training or supervisory experience is required.

LICENSES, REGISTRATIONS, CERTIFICATIONS: 

• State of Michigan license required if a registered nurse, counselor or social worker.
• Formal certification as a clinical research coordinator, preferred.

OTHER SKILLS AND ABILITIES: 

• High level of communication skills to effectively interact with study sponsors and vendors, faculty, staff, students, patients, and families.
• Demonstrated experience in creating strong recruitment plans for clinical trials.
• Advanced working knowledge of Microsoft Word, PowerPoint, Excel, Redcap and/or other Statistical Software.
• Previous experience doing psychological testing is desired but not required.
• Advanced knowledge of clinical trials, investigator-initiated protocols, and FDA and IRB regulations.
• Outstanding judgment, initiative and attention to detail are essential. Must be able to manage competing priorities while supporting more than one project.
• Demonstrates superior knowledge of research protocols and clinical, scientific and/or medical terminology.
• Experience creating detailed Source Documents according to the protocol and EDC guidelines.
• Ability to effectively communicate with others verbally and in writing.
• Excellent interpersonal skills.
• Ability to apply technology and innovation to improve efficiency and solve problems.
• Ability to interpret complicated and detailed data accurately, and develop insightful reports.
• Meticulous attention to detail and data integrity.
• Ability to travel to affiliated hospital, clinics, and work nights, weekends and holidays when requested.
• Demonstrates the ability to recognize priorities in organization of workflow.
• Able to perform duties independently, with a minimal need for direct supervision but expected to seek guidance from experienced staff.