Description

The Division of Gastroenterology and Hepatology is consistently ranked by U.S. News and World Report as a top program nationally and is 1 of the largest divisions in the country with wide-ranging and reaching clinical and research expertise.

Job Summary

We are seeking a Clinical Research Leader to help continue our distinguished tradition of excellence in patient care, innovation, and education in the Division of Gastroenterology and Hepatology. The Clinical Research Leader would be overseeing our Liver, ERCP, EUS, IBD, Motility, and General GI research teams.
General Responsibilities

• Provides highest level of operational leadership and coordination of assigned staff members for clinical research operations and activities
• Provides direction and guidance on high priority and/or complex clinical research projects/initiatives
• Conducts a variety of personnel actions to include, but not limited to hiring, training, promotion, performance management, and dismissal
• Develops and educates on departmental policies and procedures to ensure the efficient operation of both clinical trials and related patient care; establishes standard operating procedures for clinical research operations/activities and ensures compliance with all internal and external requirements of regulatory agencies
• Evaluates protocol, studies design, and assesses risk to subject population
• Manages staff assignments and allocation of clinical research resources, including determining staff and facility availability
• Assesses study population/availability; reviews and critically evaluates study contract(s)/letter(s) of agreement
• Prepares and negotiates budget; prepares payment schedule with sponsor(s); negotiates fees for associated services
• Manages study account(s) and ensures that expenditures do not exceed contracted amount and are appropriate/approved
• Oversees and establishes processes/procedures for the proper screening of study subjects
• Ensures that Informed Consent forms are explained to study participants and all required signatures are obtained prior to start of study
• Establishes, implements, and ensures quality assurance for clinical research operations
• Seeks peer-review for quality assurance practices that retrospectively evaluates accuracy and timeliness of study completion and/or identifies potential protocol violations
• Communicates with sponsors concerning progress of clinical research, budgetary updates, patient study-related problems or concerns, recruitment strategies and specific policies and procedures
• Acts as liaison between clinical research staff and study sponsors, Institutional Review Board (IRB), federal, state and university officials and other regulatory agencies to maintain regular communication of costs, policy changes, fiscal requirements, and other regulatory issues
• Serves as representative and advisor for clinical research operations on appropriate university committees, work groups and task forces
• Researches and stays up-to-date with new research developments by attending continuing education meetings, lectures, training sessions and/or 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 / WORK EXPERIENCE
Required

• Master's degree plus 2 years in clinical research, including supervisory experience; OR
• Bachelor's degree in science or health-related field plus 4 years of experience in clinical research, including supervisory experience; OR
• Associate's degree in allied health plus 5 years of experience in clinical research, including supervisory experience

LICENSES AND CERTIFICATES
Required

• ACRP or SOCRA clinical research certification upon date of hire

SKILLS
Required

• Proficient written and verbal communication skills
• Maintains a high degree of professionalism
• Demonstrates 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
• Demonstrates excellent judgment and decision making skills
• Effective conflict management skills
• Builds and manages effective teams

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.

Work Location

Indianapolis, Indiana
This position is eligible for remote work or to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.

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: Sr. Operational
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
Click here to learn more about Indiana University's Job Framework.

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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.