Clinical Research Coordinator

Indiana University Northwest; Indianapolis (IN); Hybrid; USD 55,848 - 74,006; Full time

Benefits offered by this job

Medical insurance

Dental insurance

HSA contributions

Flexible spending accounts

Life insurance

Disability insurance

Retirement plan

Tuition assistance

Paid holidays

Paid leave

Volunteer time

Job summary

Indiana University Indianapolis is seeking a project manager in the Department of Medical and Molecular Genetics to oversee day-to-day clinical research activities and team coordination. You will manage participant recruitment, data collection, budget oversight, protocol adherence, and timely delivery of study deliverables to sponsors and external partners.

The role emphasizes regulatory submissions, proposal development, and collaboration with investigators, vendors, and community advisory

Qualifications

• Requires a Bachelor's degree in science or health field.
• Minimum 5 years of clinical research experience.
• SOCRA/ACRP clinical research certification by date of hire.

Responsibilities

• Oversee day-to-day project activities and staff interactions with participants and data collection.
• Manage recruitment and consent processes according to approved methodologies.
• Maintain budget oversight and prepare sponsor budget modifications as needed.
• Coordinate project closure, deliverables, and data handoffs to sponsors and stakeholders.
• Develop project plans, risk management, and required participant materials.
• Coordinate team activities and ensure staff have support and clear schedules.
• Assist in writing and submitting research proposals and regulatory documents.

Skills

Project management

Clinical research

Regulatory compliance

Budget oversight

Communication

Education

Bachelor's degree in science or health field

Job description

Department Information

One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institute of Health Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.

Job Summary

• 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 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

• 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.

Additional Information

This position is not eligible for visa sponsorship.

Work Location

Indiana University Indianapolis

Indianapolis, Indiana

This position is eligible for remote work or in-person work. However, this is subject to change in the future based on university policy and business need.

Advertised Salary

$55,848.00 per year to $74,006.40 per year based upon experience and internal equity within the department.

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

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