Job Summary The Clinical Research Leader is responsible for setting work priorities, resolving operational issues, and implementing process improvements to enhance efficiency. Key duties include managing the employment lifecycle from hiring and performance reviews to corrective actions while ensuring adherence to institutional policies. By managing trial feasibility and execution, the Lead ensures research integrity.
Department-Specific Responsibilities
- Provides technical guidance and fosters the career development of the coordinator team.
- Analyzes and monitors staff performance metrics to set strategic work priorities, delivering targeted training and comprehensive performance reviews to ensure high-quality research output.
- Evaluates the clinical trial portfolio against current capacity to ensure optimal staffing levels and resource allocation, maintaining operational efficiency as the division grows.
- Oversees the end-to-end conduct of clinical studies, ensuring strict adherence to protocol, safety standards, and timely submission of all regulatory reporting requirements.
- Serves as the primary point of contact between research staff, sponsors, Institutional Review Boards (IRB), and government officials to facilitate accurate communication and consistent application of complex policies and procedures.
General Responsibilities
- Provides operational leadership and administrative direction for clinical research activities.
- 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 IRB and properly documented on source documents.
- Designs and implements proper data management for data collection and tracking and/or oversee 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.
- Assists 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 keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences
Qualifications Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
EDUCATION
Required - Bachelor's degree (preferably in science or a health-related field)
Preferred WORK EXPERIENCE
Required - 2 years clinical research 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
Preferred - Registered Nurse in the State of Indiana upon date of hire
SKILLS
Required - 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
Working Conditions / Demands The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.
Additional Information This position is not eligible for visa sponsorship.
Work Location Indianapolis, Indiana
Advertised Salary $80,000.00 - 85,000.00 annually based on a combination of experience, skill level, education, and training.
Benefits Overview For full-time staff employees, Indiana University offers a wide array of benefits including:
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- Healthcare and dependent care flexible spending accounts
- Basic group life insurance paid by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
- Base retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan options
- Tuition subsidy for employees and family members taking IU courses
- 10 paid holidays plus a paid winter break each year
- Generous paid time off plans
- Paid leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
Learn more about our benefits by reviewing the IU Benefit Programs Brochure .
Job Classification Career Level: Operational
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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Posting Disclaimer This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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