Clinical Research Coordinator
Indiana University

Job Info

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Department

CLINICAL GENETICS (IN-CLNG-IUINA)

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 NIH 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

Department-Specific Responsibilities

• Responsible for overall management of all clinical research studies financials.
• Assists with preparing and negotiating budgets and prepares payment schedule with sponsor(s);
• In coordination with the Clinical Research Leaders, negotiates fees for associated services and ensures accurate project invoicing/billing.
• Manages clinical research accounts and ensures expenditures are appropriate and do not exceed contracted amounts.
• Reconciles projects budget accounts with department business office and provides ad-hoc reports upon requests.
• Monitors personnel effort allocations and advises financial leaders of changes.
• Ensures adherence to grant sponsors, IRB and university accounting and grant administration guidelines.
• Assists with some studies to help with the growing workload/awarded clinical studies.

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 health related field

WORK EXPERIENCE

Required

• 5 years of clinical research experience

LICENSES AND CERTIFICATES

Required

• SOCRA/ARCP Clinical Research Certification upon date of hire

SKILLS

Required

• Proficient communication skills
• Maintains a high degree of professionalism
• Demonstrated 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

IU Indianapolis

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 needs.

Advertised Salary

$63,913.04 - $73,913.04 per year based on experience and internal equity within the department.

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Multiple plan options for medical insurance
• Dental insurance
• Health Savings Account with generous IU contribution
• Life insurance, LTD, and AD&D options
• Base retirement plan contribution from IU, subject to vesting
• Additional supplemental retirement plan options
• Tuition benefit for IU classes
• 10 paid holidays per year
• Generous Paid Time Off
• Paid Parental Leave
• Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits 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.

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 employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's 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.

Contact Us

Request Support
Telephone: 812-856-1234

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