Clinical Research Coordinator Behavioral Health

About the Role:

A Behavioral Health Clinical Research Coordinator (BH CRC) plays a pivotal role in the successful implementation and management of clinical research studies involving addiction, PTSD, depressive disorders, etc. This role involves coordinating and overseeing all aspects of research studies, including patient recruitment, data collection, documentation, and compliance with regulatory and ethical guidelines.

Minimum Qualifications:

• Bachelor's degree in Psychology, Nursing, Public Health, or a related field.(Required)
• Experience in clinical research coordination, preferably within behavioral health or mental health settings.
• Knowledge of clinical research regulations, including Good Clinical Practice (GCP) and Institutional Review Board (IRB) processes.
• Strong organizational and communication skills with attention to detail.
• Ability to work effectively with diverse populations and maintain confidentiality.

Preferred Qualifications:

• (Required) Bachelor's degree and/or license such as C-MA or LPN
• One to two years' experience working in a CRC role within the psychiatric/behavioral health space; OR an equivalent combination of the above education and experience
• Must have behavioral health and psychology clinical research experience
• Knowledge of medical terminology
• Strong team player with interpersonal skills
• Must be able to work in a high paced environment
• Exceptional organizational and time management skills, ability to prioritize tasks - detailed oriented
• Computer skills (familiar with electronic health record systems, Microsoft Office)

Responsibilities:

1. Patient Recruitment and Enrolment: Identifying and screening potential study participants according to study eligibility criteria. Facilitating the informed consent process, explaining study details, benefits, and risks to potential participants, and managing participant enrollment.

2. Data Collection and Management: Collecting, recording, and managing research data accurately and efficiently. This may involve gathering information from medical records, conducting interviews or questionnaires with study participants, performing physical examinations, and maintaining study databases or electronic data capture systems.

3. Study Visits and Procedures: Coordinating and conducting study visits and procedures, ensuring that all required assessments, tests, and interventions are carried out according to the study protocol. This includes administering study drugs or interventions, collecting samples (e.g., blood, urine) for testing, and ensuring participant safety during all study procedures.

4. Regulatory Compliance: Ensuring compliance with all applicable regulatory and ethical guidelines, including Good Clinical Practice (GCP) standards, local regulations, and Institutional Review Board (IRB)/Ethics Committee requirements. This involves obtaining necessary approvals, maintaining study documentation, and facilitating regulatory inspections or audits.

5. Participant Monitoring and Safety: Monitoring and assessing participant safety throughout the study. This may include managing adverse events or side effects, providing education and support to participants, and promptly reporting any safety concerns to the study team and regulatory authorities.

6. Collaboration and Communication: Collaborating with the research team, investigators, study sponsors, and other stakeholders to ensure effective communication and coordination. This involves participating in study team meetings, providing updates on study progress, and resolving any issues or challenges that arise during the course of the study.

7. Quality Control and Documentation: Maintaining accurate and complete study documentation, including case report forms, source documents, and regulatory files. Performing quality control checks to ensure data accuracy and adherence to protocol requirements.

8. Education and Training: Providing education and training to study participants, healthcare providers, and research staff on study protocols, procedures, and regulatory requirements. This includes conducting study-specific training sessions, providing ongoing support and guidance, and ensuring staff competency in all aspects of the research study.

Overall, a Clinical Research Coordinator is responsible for coordinating and supporting the day-to-day operations of clinical research studies, ensuring adherence to regulatory requirements and ethical standards, and contributing to the generation of high-quality research evidence. This role requires strong organizational and communication skills, attention to detail, and the ability to work effectively within a multidisciplinary team.

Skills:

The required skills enable the CRC/Behavioral Health professional to efficiently manage complex clinical research protocols while ensuring participant safety and data integrity. Strong organizational skills are essential for coordinating multiple study activities and maintaining compliance with regulatory standards. Effective communication skills facilitate collaboration with research teams, healthcare providers, and study participants, ensuring clear understanding and adherence to study requirements. Attention to detail is critical for accurate data collection, documentation, and reporting, which directly impacts research validity. Preferred skills such as proficiency with clinical trial software and bilingual abilities enhance the ability to engage diverse populations and streamline research processes, ultimately contributing to successful study outcomes.

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