Provides day-to-day operational oversight of the Clinical Core team and the assignment of project-related work to all clinical research specialists and coordinators, neuropsychological testers, interns and trainees.
Consents subjects and ensures that informed consent forms are properly signed before the study procedures are undertaken.
Conducts Neuropsychological Training and Assessment for certification.
Prepares (or oversee the preparation of) documentation pertaining to subjects including research visit charts and mailings.
Prepares (or oversee the preparation of) research charts for entry into databases; oversee data quality assurance practices.
Using universal precautions, handles blood and urine specimens as outlined in research protocols.
Facilitates the transfer of blood and urine specimens to designated central labs.
Coordinates and manages consensus diagnosis meetings with clinicians.
Manages and supervises the preparation and dispatch of consensus letters ensuring accuracy and timely delivery.
Assists with the identification of research participants; determines eligibility according to the protocol and NIA designated priority groups.
Conducts study visit activities and coordinate consenting, scheduling of testing, exams, and assessments; coordinate, facilitate, and perform various study activities; manage all follow-up activities with subjects based on protocols.
Records study data, samples, and results in various databases; performs data quality and pursues resolutions to erroneous data; produces various reports in response to requests from PI and other IADRC faculty members.
General Responsibilities
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
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.
Oversees and 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 2 years of clinical research experience; OR
Associate's degree in science or a health-related field and 3 years of clinical research experience
LICENSES AND CERTIFICATES
Preferred
SOCRA/ARCP Clinical Research Certification upon date of hire
SKILLS
Required
Demonstrates 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.
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: Career
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 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
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