Clinical Research Coordinator at Indiana University in Indianapolis, Indiana

Job Description:

Department



PHYSICAL THERAPY (IN-PT-IUINA)



Department Information




Job Summary



The Clinical Research Coordinator will work within the Musculoskeletal Function, Imaging, and Tissue Resource Core (FIT Core) which is physically located in IU Health University Hospital. The FIT Core assesses research participants for investigators. Since its inception in 2017, the FIT Core has assessed over 3,500 research participants and entered their data and biospecimens into data repositories.


Department-Specific Responsibilities

• Assesses physical function such as walking speed, grip strength, and balance.


• Performs quantitative imaging outcomes for bone health and body composition using dual-energy x-ray absorptiometry and high-resolution peripheral quantitative computed tomography.


• Collects, processes, and banks biospecimens.


• Initiates and conducts protocol review, evaluations, study design, and risk assessments of FIT Core led studies.


• Works with investigators, their personnel, and the IRB to integrate FIT Core held IRB protocols and services in investigators' parent IRB protocols.


• Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary) and conducts reviews, evaluations, and risk assessments for FIT Core held IRB protocols.


• Monitors enrollment goals and modifies recruitment strategy, as needed, for FIT Core held IRB protocols.


• Develops informational materials to advertise FIT Core services and for the recruitment of FIT Core participants.


• Identifies and selects potential FIT Core participants by reviewing existing protected health information, screening subjects, and conducting interviews.


• Assists and co-supervises the FIT Core's Clinical Imaging Technician to ensure musculoskeletal imaging outcomes are performed, analyzed, and interpreted according to standard operating procedures.


• Performs subject interviews and assessments for data required by protocol(s), including musculoskeletal imaging.


• Collects and processes biospecimens from study participants for storage in the Indiana Biobank for later retrieval.


• Records, documents, and reports protocol deviations and trial changes to the PI and sub-investigators, and submits deviations and trial changes to IRB.


• Reviews subject adverse event (SAE) information, and assists investigators in making submission determination of SAEs, and follows up to determine resolution of adverse events.


• Stays up to date with knowledge of regulatory affairs and/or issues, including IRB, radiation safety, and Good Clinical Practices.


• Develops solutions to problems that impact the timeliness and accuracy of the conduct of clinical research studies within the FIT Core.

General Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.


• Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects.


• Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits.


• Manages all follow-up activities with subjects based on protocols and oversees proper documentation at study close-out.


• Participates in study budget negotiations and reconciles study budget accounts.


• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.


• Ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.


• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).


• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)


• Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.


• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).


• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.


• Stays up to date with knowledge of regulatory affairs and/or issues.

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

• Bachelor's degree in science or a health-related field and 1 year of clinical research experience; OR
  


• Associate's degree in science or a health-related field and 2 years of clinical research experience.

LICENSES AND CERTIFICATES



Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire .

SKILLS



Required

• Demonstrated analytical skills.


• Ability to simultaneously handle multiple priorities.


• Possesses strong technical aptitude.


• Demonstrates a high commitment to quality.


• Excellent organizational skills.

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



Advertised Salary



$45,000 - $48,000 per year based on experience.



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: Core


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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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.



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