Clinical Research Leader

About the role

The Division of Clinical Pharmacology in the Department of Medicine at Indiana University (IU) School of Medicine provides operational leadership and administrative direction for clinical research activities. It bridges the gap between science and the practice of medicine through innovative research, development, and regulation of medications.

Responsibilities

• Analyzes, monitors, and evaluates performance of assigned staff; establishes work priorities, provides training, conducts performance reviews, and provides corrective action as needed.
• Ensures adequate staffing and effective scheduling; participates and informs employment decisions for assigned staff.
• Develops and coordinates departmental policies and procedures to ensure the efficient operation of both clinical trials and patient care; establishes standard operating procedures for the clinical research unit and ensures compliance with all internal and external requirements of regulatory agencies.
• Evaluates protocol, study design, and assesses risk to subject population; monitors enrollment goals and modifies participant recruitment strategy, as necessary.
• Oversees and ensures the implementation of the Principal Investigator's (PI) recommendation for adverse event interventions; ensures that serious adverse events are reported to sponsor and Institutional Review Board (IRB) and properly documented on source documents.
• Designs and implements proper data management for data collection and tracking and/or oversees design of such databases.
• Oversees the proper documentation at close-out as required by sponsor including return or disposal of unused supplies, reconciliation of test article accountability, study summary, evaluation of team efforts, and study ""drop outs"" and other required reports.
• Aids and contributes to budget preparation and ensures adherence to grant sponsors, IRB and, university accounting and grant administration guidelines.
• Acts as liaison between the research staff and the sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues.
• Expands knowledge base and keeps abreast with new research developments by attending continuing education meetings, lectures, training sessions, and conferences.

Requirements

• Education: Bachelor's degree (preferably in science or health-related field), with a Master's degree preferred.
• Experience: 2 years clinical research experience, with supervisory experience preferred.
• Licenses and Certificates: Required Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire, with Registered Nurse (RN) in the state of Indiana upon date of hire preferred.

Skills

• Proficient written and verbal communication skills.
• Maintains a high degree of professionalism.
• Demonstrated time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Excellent organizational skills.
• Excellent collaboration and team building skills.
• Effectively coaches and delivers constructive feedback.
• Instills commitment to organizational goals.