Clinical Trials Operations Consultant (Clinical Research Coordinator)
The Clinical Research Administration unit supports and leads clinical research efforts across 9 Department of Medicine divisions.
Job Summary
Department-Specific Responsibilities
- Leads operational feasibility reviews with principal investigators (PI).
- Coordinates with contracting, budgeting, and regulatory teams for process alignment.
- Builds predictable activation timelines based on study type/complexity.
- Tracks bottlenecks and proposes operational fixes (e.g., template language, standard budget grids).
- Supports standardization by upskilling Clinical Research Centers (CRC) and improving team readiness.
- Helps to establish and implement Department of Medicine (DoM) study start up procedures.
- Assists with Institutional Review Board (IRB) submissions (initial, continuing review, amendments).
- Prepares regulatory binders and essential documents.
- Coordinates contract/budget logistics with sponsors and research administration.
- Develops study workflows within clinic operations.
- Sets up study materials (CRFs, REDCap, source templates).
- Prepares for sponsor site initiation visits.
- Maintains training curriculum aligned to good clinical practice (GCP), standard operating procedures (SOP), and process improvements.
- Develops onboarding pathways for CRCs and new hires.
- Conducts periodic quality assurance (QA) reviews and feedback loops for teams (mirroring Clinical Research Leader QA expectations).
- Supports certification readiness (Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP)).
- Assists in building subject identification workflows.
- Develops recruitment tracking dashboards, materials and strategies.
- Tracks enrollment barriers and implements process fixes (e.g., automated screening tools, pre-screening criteria).
- Creates "enrollment rescue plans" for underperforming trials.
- Oversees documentation standards across CRC teams.
- Runs periodic audits (regulatory binders, consent processes, deviation tracking).
- Liaises with IRB office to ensure process alignment.
- Creates risk mitigation frameworks for common protocol deviations.
- Leads special initiatives tied to upcoming strategic plans or trial expansion.
- Supports the Director of Research Administration.
- Builds business cases for resource allocation (CRC staffing, FTE leveling).
- Conducts performance analytics and forecasting for trial volume, staffing, and activation timelines.
- Supports partnerships (industry, academic collaborations).
General Responsibilities
- Oversees day-to-day activities of the projects.
- Manages project staff's interaction with participants and data collection; assesses and ensures that staff follow protocols and standard operating procedures.
- Manages the recruitment of study participants according to approved methodologies; ensures that study staff correctly assess eligibility and carry out the informed consent process with participants.
- Measures projects' progression toward successful completion of project goals; plans and ensures all corrective action and implementation.
- Maintains fiscal oversight; prepares budget modification requests to sponsor as needed; reconciles study budget accounts with business manager.
- Oversees proper project closure including finalizing all qualitative and quantitative data and handing off any project deliverables such as study created decision aids, educational materials, and result summaries to the sponsor, stakeholders, and external partners.
- Coordinates the design and development of all databases that will ensure the accurate tracking of all individuals approached for studies and the safety and security of all data.
- Determines the activities, sequence and time allotted for each activity, and the resources required to achieve the projects' goals.
- Develops project plans including risk management plans; continuously assesses and updates the plans throughout the projects' life cycle.
- Works with project teams to develop all required material including but not limited to advertising, recruitment brochures and letters, surveys, and educational materials for research participants and stakeholders.
- Coordinates activities of the project team including staff, operations support, consultants, vendors, patient, and community advisory boards, and co-investigators; fosters accountability and ensures that all project team members feel supported in their roles.
- Develops schedules for project staff.
- Assists in developing, writing, and submitting research proposals. Coordinates meetings and compiles proposal documents. Writes sections of the proposal especially the methods and human subjects' sections. Prepares the proposal budget and justification in conjunction with other stakeholders.
- Responsible for accurate preparation and timely submission of all regulatory documents.
- Maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and attending continuing education classes.
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 in a science or a health related field.
WORK EXPERIENCE
Required
- 5 years of clinical research experience.
LICENSES AND CERTIFICATES
Required
- Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) 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.
- Possesses flexibility to work in a fast paced, dynamic environment.
- Seeks to acquire knowledge in area of specialty.
- Highly thorough and dependable.
- Demonstrates a high level of accuracy, even under pressure.
- Possesses a high degree of initiative.
- Ability to influence internal and/or external constituents.
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 a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
Advertised Salary
$63,730.00 - 73,730.00 depending on experience and internal pay equity.
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: Advanced
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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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 .
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