Clinical Research Specialist I

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Job Title

Clinical Research Specialist I

Department

Medicine | Psychiatry

Job DescriptionClinical Research Associate Coordinator serves as a supportive resource in the Department of Psychiatry and Behavioral Health in the execution of assigned clinical research studies in accordance with approved protocols administered by the Department of Psychiatry and Behavioral Health; evaluates and implements designated aspects of new research strategies; participates in developing and implementing processes for patient data management; collaborates with the Principal Investigator to develop and implement study participant consenting processes to comply with sponsor and federal regulations; develops and implements plans to meet requirements of new studies; oversees and manages planning, implementation and execution of data protocols from adolescent substance use research studies; plans and supervises daily data management activities of the clinical research staff; supervises clinical research data collection, management, and reporting; collaborates with investigators to develop research protocols and assists with writing and preparation of grant applications to obtain research funding; participates and leadswriting and submission of manuscripts and articles for publication and presentation; assists with activities to ensure compliance with Institutional Review Boards (IRB); conducts quality assurance reviews of research processes and data; ensures compliance to federal, state and local regulations and guidelines; plans, coordinates and participates in site visits by research sponsors and regulatory agencies as needed; recruits, hires, trains, evaluates and directly supervises clinical research staff; experienced in crisis prevention and management.

Minimum Education Required: Bachelor's Level Degree with a Major in psychology, neuroscience, biological sciences, or healthcare administration.

Required Qualifications: Bachelors Degree in psychology or neuroscience; knowledge of clinical research regulations, guidelines & compliance issues required including Institutional Review Board (IRB) & federal or industry sponsor processes and requirements; supervisory experience preferred; experience with large datasets, storage, and NDA sharing strongly preferred; experience in clinical research in adolescent substance use and social determinants of health strongly preferred; experience writing research grants and proposals strongly desired; knowledge of medical terminology desired; computer skills required with experience using Microsoft Software and R studio applications desired. Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.

Function: Research and Scholarship

Sub Function: Clinical Research

Career Band: Individual Contributor Series-Specialized

Career Level: S1

Additional Information

Location:

Remote Location

Position Type

Regular

Scheduled Hours

40

Shift

First Shift

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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