Clinical Research Coordinator

Indiana University
August 2, 2020
Indianapolis, IN
Job Type




Job Summary

This position will initiate, conduct, complete, and report clinical research/ assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research. Work with Principal Investigator in implementing and maintaining quality improvement research projects in primary care practices. Tasks include working with clinical practices to develop and coordinate quality improvement activities at study practice sites that meet what goals of the project and can be maintained long-term within the practice setting. Development of these goals will also need to ensure that the protocol, regulatory and SOP's and GCP are in compliance. This position also plays an integral part in developing solutions to complex problems that impact the timely and accurate conduct of the quality improvement projects with the primary care practices.

Provide overall supervision and administrative direction to all clinical research activities within Nephrology conducted at Non-VA locations. Provide supervision of clinical research personnel and support staff. Perform various personnel functions including recruitment, project assignments, training, performance appraisals, and discipline. Provide staff with adequate workspace and materials. Problem solving with research personnel to develop a project that will be effective and be able to be maintained after the project is completed. Develop and coordinate departmental policies and procedures to ensure the efficient operation. Establish standard operating procedures for the clinical research unit and ensure compliance with all internal and external requirements of regulatory agencies. Train/educate the ancillary staff regarding the clinical trial. Ensure the continuing education for all staff as appropriate. Oversee the orientation and training of new staff.

Oversee all day-to-day development, implementation, evaluation, and quality control activities of research projects. Assist in developing solutions to problems in the project as they occur. Access and extract information for protocol development for investigator initiated trials. Participate in preparation and negotiation of study budget. Reconcile study budget accounts with Business Manager. Review, critically evaluate and comment on study contracts/agreement. Prepare and submit Institutional Review Board (IRB) documents (i.e.) Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor. Develop advertising and other information materials for recruitment. Identify and schedule screening procedures and review results. Design recruitment strategies. Monitor enrollment goals and modify recruitment strategy as needed. Monitor study team compliance with required study procedures and GCP standards. Extract data from source documents. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Record and document protocol deviations. Communicate with PI and sub-investigators about changes in the trial. Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs. Maintain follow-up to determine resolution of adverse event. Compose and submit continuing review/amendments/close out information. Audit documents and pertinent files and prepare for storage. Archive documents for study per sponsor/government/institutional requirements.

Act as a liaison between the research staff and the staff at the practice setting. Work with other research personnel to ensure needs of both clinic and project are being met. Resolve sponsor queries. Contact outside healthcare providers to obtain follow-up information. Communicate with subjects to obtain follow-up information. Recruit subjects according to IRB/protocol approved methodologies┬┐ consent subjects including discussion of treatment and intervention alternatives and ensure that Informed Consent forms are properly signed before the start of the study.

Expand knowledge and keep abreast with new research developments by attending continuing education meetings, lectures, training sessions and conferences. Ensure the continuing education for all staff as appropriate. Coordinate the orientation and training of new staff.

Communicate with investigator and practice staff concerning progress of the projects, study related problems, and specific policies and procedures. Prepare written reports and project correspondence. Assist with grant proposal writing and submit new proposals for additional future funding.

This position will operate without daily oversight. Issues related to the research projects will be brought forward by this position to the PI. This position is expected to be the primary resource for information related to implementing this quality improvement project in a practice setting.

Required Qualifications

Bachelor's degree in science or a health-related field and two years of experience in a healthcare/clinical setting or in clinical research.

Clinical Research Certification (ARCP or SOCRA).

Ability to effectively communicate and exchange information.

Preferred Qualifications

Master's degree.

Work Location

Indianapolis, Indiana

Job Classification

Salary Plan: PAE

Salary Grade: 3RS

FLSA: Exempt

Job Function: Research

Posting Disclaimer

Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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 without regard to 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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