University of Utah PS Clinical Research Coordinator in Salt Lake City, Utah

Details

Open Date 05/09/2018

Requisition Number PRN17153B

Job Title Clinical Research Coordinator

Working Title PS Clinical Research Coordinator

Job Grade E

FLSA Code Administrative

Patient Sensitive Job Code? Yes

Standard Hours per Week 40

Full Time or Part Time? Full Time

Shift Day

Work Schedule Summary

Monday – Friday, 8:30 am – 5:00 pm.

VP Area U of U Health - Academics

Department 00857 - Pediatric Hematology/Oncology

Location Campus

City Salt Lake City, UT

Type of Recruitment External Posting

Pay Rate Range $39,300 to $64,349

Close Date

Open Until Filled Yes

Job Summary

The Division of Hematology-Oncology in the Department of Pediatrics, University of Utah School of Medicine, has an immediate opening for a Clinical Research Coordinator. The Clinical Research Coordinator assists the clinical trials process by registering patients for clinical studies, assessing eligibility criteria, maintaining current protocol packets and assuring that all Quality Assurance measures are maintained within the protocol/study. The Clinical Research Coordinator assists the Primary Investigator in allIRBand regulatory submissions and clinical coordination specific to protocol. Coordinates the implementation, quality control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies.

Responsibilities

Essential Functions

1.In collaboration with the attending physician, recruit study subjects and ensure that all eligibility parameters are met. Ensure that informed consent is obtained prior to patient enrollment.

2.Register patients on clinical trials utilizing the appropriate registration process determined by the study group. Discuss study with subject and obtain informed consent; schedule assessment/visits; assure study visits and tests are done at appropriate time intervals.

3.Prepare packets for each newly diagnosed patient to include protocol consent, eligibility and

pre-treatment requirements.

4.Communicate process to obtain pathology and/or biology specimens as required by protocol. Coordinate the submission of specimens withPCHlaboratory according to protocol guidelines and shipping regulations.

5.Daily review of next day’s clinic records to ensure that current and correct roadmap is available. Assist Care Coordinators and LIPs in obtaining current roadmap for all inpatients.

6.Download information from clinical trial websites and maintain communication with Children’s Oncology Group (COG), Therapeutic Advances in Childhood Leukemia (TACL), Pacific Pediatric Neurooncology Consortium (PNOC), Sunshine Pediatric Sarcoma consortium, and Medulloblastoma Neuroblastoma Consortium. Maintain protocols by ensuring that new protocols, amendments and closures are updated on notification from consortia.

7.Responsible for all aspects of regulatory compliance for consortia within Primary Children’s Hospital.

8.Track all regulatory activity generated from consortia or other study governing bodies. Prepare and submit protocols, protocol amendments and necessary progress reports for all protocols toIRBfor approval in accordance with regulatory and/orIRBrequirements.

9.Assist physician investigator with communications to the various study chairs or group office as needed. Provide feedback to medical team on QA issues, protocol violations and documentation issues.

10.Prepare all necessary documents for an Institutional Audit and/or site visit Peer Review

11.Provides cross-coverage as needed to ensure that the work requirements are met. Attends to other duties as assigned by supervisor

12.Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.

Additional Functions

The Clinical Research Coordinator will also perform these functions in conjunction with existing staff and may provide cross coverage of these functions with other staff members:

1.Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.

2.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.

3.Recognizes, tracks and reports adverse events and protocol deviations.

4.Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.

5.Represents the research program at meetings, and national and international research consortia.

6.Prepares, submits and maintainsIRB,FDA,NCI,NIH,NSFand/or other regulatory documents and research correspondence.

7.Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.

8.Supervises, mentors and trains new or junior research staff.

9.Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis.

10.Develops and maintains patient databases, investigational logs and records of drugs administered, medical devices monitored and/or procedures followed.

11.Assists the Principal Investigator in the development of study protocols.

Minimum Qualifications

Bachelors degree in a health sciences or related field with two years professional research experience and completion of UniversityRATSClinical Certification within one year of hire required. Exceptional organizational skills, attention to detail, and demonstrated human relations and effective communication skills also required.

This is a patient sensitive position.

Knowledge of Good Clinical Practices,FDA,HIPAAandIRBregulations; an understanding of research procedures; and the ability to function independently is preferred.

Departments may requireIRBCITICourse orIATADGRtraining 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.

Preferences

Type Benefited Staff

Special Instructions Summary

Additional Information

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.

To inquire about this posting, email: employment@utah.edu or call 801-581-2300. Reasonable accommodations in the application process will be provided to qualified individuals with disabilities. To request an accommodation or for further information about University AA/EO policies, please contact the Office of Equal Opportunity and Affirmative Action, 201 S. Presidents Cr., Rm 135, (801) 581-8365 (V/ TDD ), email: oeo@umail.utah.edu .

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.