"MHISO Lab Research Coordinator"

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

This Clinical Research Coordinator (CRC) Associate position will support NIH- and VA-funded research projects focused on adult mental health services. This individual will provide study coordination across multiple research studies of moderate to complex design.

Knowledge of all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCP's)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

Position Specific Responsibilities will Include:

1. Interpret study protocol requirements and apply requirements to support consistent study compliance
2. Screen, recruit, consent, schedule, and administer assessments with minimal supervision
3. Coordinate research activities such as intervention delivery, clinical research billing, and participant payments via electronic systems (e.g., Oncore, MiChart, HSIP)
4. Participate in study startup activities, team meetings, and monitoring-related preparations relevant
5. Abstract electronic medical record data on treatment delivery, outcomes, and potential adverse events
6. Use the EMR and study databases to confirm eligibility and track research intervention completion
7. Assist with qualitative interview scheduling, notetaking, coding, and analysis
8. Assist with preparation and maintenance of essential regulatory documents and reports
9. Maintain thorough documentation of study activities in Case Report Forms (CRF) and incident logs
10. Maintain awareness of participant safety reporting expectations and promptly escalate concerns about suicide risk or other urgent safety issues consistent with protocol and supervision requirements
11. Complete required institutional training (e.g., PEERRS, CITI, GCP) and unit-specific training
12. Participate in training aligned with certification eligibility and completion expectations for Clinical Research Professionals (Good Clinical Practice certification training) as required for this role

Required Qualifications:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.
• + Candidates must be eligible to register or take the exam at date of hire, and the certification must be competed or passed etc. within six months of date of hire.
• +(Please review eligibility criteria from https://www.socra.org/ or https://acrpnet.org/certification/crc-certification prior to applying).
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
• Have at least one year of experience working with mental health populations in research, clinical, and/or community setting(s)
• Have at least one year of experience working on loneliness and suicide prevention behavioral intervention research
• Be able to obtain an Intergovernmental Personnel Agreement (IPA) to work on VA projects within 2 months of hire
• Be available to work evenings and weekends to support program activities

Other qualifications that will set you up well for this role:

• 4+ years of direct related experience
• At least one year of experience working with individuals in crisis and/or at high risk of suicide in research, clinical, and/or community setting(s)
• At least one year of experience coordinating behavioral intervention research in real-world clinic settings
• Experience preparing components of regulatory and proposal submissions

Standard work schedule will be Monday-Friday, 8:00 AM - 4:30 PM, with some flex hours to cover evenings and weekends as needed.