Clinical Research Specialist I

Clinical Research Specialist 1 is a supportive resource in the Department of Psychiatry and Behavioral Health, executing assigned clinical research studies using approved protocols administered by the Department of Psychiatry and Behavioral Health.

Research populations will include Spanish-speaking families. The candidate may be responsible for regularly communicating with Spanish-speaking research participants, including describing the research study, answering questions about the study, and completing recruitment and enrollment processes with Spanish-speaking participants.

The Clinical Research Specialist 1:

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 in lead writing 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 with 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; experience in crisis prevention and management.

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

Required Qualifications: Bachelor's Degree in psychology or neuroscience; knowledge of clinical research regulations, guidelines amp; compliance issues required, including Institutional Review Board (IRB) amp; 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 candidates may be requested to complete a pre-employment physical, including a drug screen.

Research populations will include Spanish-speaking families. The candidate may be responsible for regularly communicating with Spanish-speaking research participants, including describing the research study, answering questions about the study, and completing recruitment and enrollment processes with Spanish-speaking participants.

Function: Research and Scholarship

Sub Function: Clinical Research

Career Band: Individual Contributor Series-Specialized

Career Level: S1