|Job Title||Clinical Research Coordinator|
|Working Title||Clinical Research Coordinator|
|Patient Sensitive Job Code?||No|
|Standard Hours per Week||30|
|Full Time or Part Time?||Full Time|
|Work Schedule Summary|
|Department||00810 - Scient Comp & Imag Instit-Oper|
|City||Salt Lake City, UT|
|Type of Recruitment||External Posting|
|Pay Rate Range||DOE|
|Open Until Filled||Yes|
|Job Summary||The Scientific Computing and Imaging (SCI) Institute at the University of Utah has an immediate opening for a Clinical Research Coordinator. The SCI Institute is internationally recognized leader for innovative research in visualization, scientific computing, and image analysis applied to a broad range of domains. One application area at SCI is the use of computational modeling, interactive visualization and telemedicine to improve the lives of patients with a wide range of neurological and psychiatric disorders. The Clinical Research Coordinator will work with SCI faculty on a wide range of prospective clinical and population health studies including ongoing federally funded clinical trials as well as the new International Neuromodulation Registry and the Transcranial Magnetic Stimulation (TMS) program. The successful candidate will have excellent organization and communication skills and will be responsible for several aspects of our ongoing research.
|Responsibilities||Prepares, submits and maintains IRB, NIH, NSF and/or other regulatory documents and research correspondence. In collaboration with faculty at the SCI Institute, recruit study subjects and ensure that eligibility criteria are met.
Registers patients on clinical studies. Discusses study with subject and obtains informed consent; schedules assessment/visits; assures study visits and tests are done atappropriate time intervals.
Monitors enrollment goals and initiates strategies to promote enrollment and participant compliance. Coordinates and performs responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent, answering subject inquiries, overseeing study visits and acting as a liaison between participants and study-related parties.
Recognizes, tracks and reports adverse events and protocol deviations.
Daily review of next day’s clinic records as needed. Maintains protocols by ensuring that new protocols, amendments and closures are updated on notifications. Prepares and submits protocols, protocol amendments and necessary progress reports for all protocols to IRB for approval in accordance with regulatory and/or IRB requirements. Assists Principal Investigator with communications to the various study sites on a regular basis. Provides feedback to medical team on QA issues, protocol violations and documentation issues. Prepares all necessary documents for an Institutional Audit and/or site visit Peer Review Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis. Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed. Assists the Principal Investigator in the development of study protocols. Additional Functions
The staff member will also perform these functions in conjunction with existing staff and may provide cross coverage of these functions with other staff members:
The candidate decides how to best accomplish the daily requirements of various study objectives, prioritizes and delegates workload and establishes systems needed to achieve specific study goals. Efforts of multiple departments ordisciplines must be coordinated to ensure effective follow through andcompliance of all involved. The incumbent functions independently under minimal supervision using Good Clinical Practice, IRB, NIH, NSF and/or other regulatoryagency guidelines and seeking council from the Principal Investigator asnecessary.
Provides transparent, clear directives and constructive, professional communication with Program Manager to promote uniformity. Actively attends and participates in meetings as needed. Assists in the development, implementation and enforcement of Standard Operating Procedures (SOPs) Ensures completeness in appropriate AE and SAE reporting requirements as well as deviation reporting to sponsors and the IRB. Facilitates cooperative and collaborative institutional relationships. Ensures PI and MD satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through. Minimum Qualifications
Bachelor’s degree in a health sciences or related field with at least two years of clinical research experience that includes IRB application submission, and experience in human subjects research preferred. Completion of University RATS Clinical Certification within one year of hire is required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication are skills also required.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; the ability to function independently.
CITI and GCP course completion and certifications.
Must have a working knowledge of regulatory compliance; an understanding of medical terminology and technical writing experience preferred. Excellent interpersonal communication (including oral and written) and leadership skills also preferred. Must be proficient in Microsoft Office and have the ability to learn new software programs.
Hiring department may require certification by an appropriate certifying body within two years of hire.
|Minimum Qualifications||Bachelors degree in a health sciences or related field with two years professional research experience and completion of University RATS Clinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.
Knowledge of Good Clinical Practices, FDA, HIPAA and IRB regulations; an understanding of research procedures; and the ability to function independently is preferred.
Departments may require IRB CITI Course or IATA DGR training within a specified timeframe.
Departments may prefer a nursing degree for this position, which requires the incumbent to have two years related experience and possess a nationally recognized research compliance certification.
Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.
|Special Instructions Summary|
The University of Utah is an Affirmative Action/Equal Opportunity employer and is committed to diversity in its workforce. In compliance with applicable federal and state laws, University of Utah policy of equal employment opportunity prohibits discrimination on the basis of race or ethnicity, religion, color, national origin, sex, age, sexual orientation, gender identity/expression, veteran’s status, status as a qualified person with a disability, or genetic information. Individuals from historically underrepresented groups, such as minorities, women, qualified persons with disabilities, and protected veterans are strongly encouraged to apply. Veterans’ preference is extended to qualified applicants, upon request and consistent with University policy and Utah state law.
The University is a participating employer with Utah Retirement Systems (“URS”). To be eligible for retirement contributions, you must be hired into a benefit-eligible position. Certain new hires are automatically assigned to the URS retirement plan and other employees with prior URS service, may elect to enroll in the URS within 30 days of hire. Regardless of whether they are hired into a benefit-eligible position or not, individuals who previously retired and are receiving monthly retirement benefits from URS must notify the Benefits Department upon hire. Please contact Utah Retirement Systems at (801)366-7770 or (800)695-4877 or the University’s Benefits Department at (801)581-7447 for information.
This position may require the successful completion of a criminal background check and/or drug screen.
Posting Specific QuestionsRequired fields are indicated with an asterisk (*).
- * Do you have a related Bachelor's degree or equivalency? (2 years related work experience may be substituted for 1 year of education)
- * Please indicate the number of years of professional research experience that you have:
- Less than 1 year
- 1 year or more, but less than 2 years
- 2 year or more, but less than 4 years
- 4 years or more, but less than 6 years
- 6 years or more
Applicant DocumentsRequired Documents
- Cover Letter