PS Research Associate

University of Utah; Utah; On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated Research Coordinator to oversee the implementation and quality control of research studies. This role involves coordinating with various stakeholders, ensuring compliance with regulatory guidelines, and managing study budgets. The ideal candidate will possess exceptional organizational skills and a strong background in clinical research. With a focus on patient safety and effective communication, this position offers a unique opportunity to contribute to impactful research initiatives. If you are passionate about advancing public health and thrive in a collaborative environment, this role is perfect for you.

Benefits

Utah Retirement Systems participation

Professional development opportunities

Health insurance

Flexible working hours

Qualifications

• Completion of University RATS Clinical Certification within one year of hire required.
• Knowledge of Good Clinical Practices, FDA, HIPAA, and IRB regulations preferred.

Responsibilities

• Oversees compliance to protocol and manages quality control of study documentation.
• Monitors enrollment goals and initiates strategies to promote participant compliance.

Skills

Organizational Skills

Effective Communication

Attention to Detail

Problem Solving

Knowledge of Good Clinical Practices

Analytical Methods

Education

Bachelor’s degree in health science or related field

Master’s of Science degree in public health

University RATS Clinical Certification

Tools

SAS

STATA

Endnote

Job description

Priority Review Date (Note - Posting may close at any time)

Job Summary

Coordinates the implementation, quality control and completion of the study 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.

This position is patient-sensitive and must fulfill all associated requirements. We protect our patients, coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations.

Office Location: 250 S 200 E Salt Lake City, UT

Responsibilities

Essential Functions:

• Oversees compliance to protocol; manages quality control, completion and submission of study related documentation; prepares reports for organizations and agencies.
• Develops study budgets; monitors budget expenses and billing for allied services; negotiates payment schedule with sponsor and fees for internal services.
• 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.
• Prepares for and coordinates site visits made by sponsors or federal agencies during course and at the close of the study.
• Represents the research program at meetings, national and international research consortia.
• Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence.
• Contributes to developing educational materials and educates the community and other research professionals regarding studies and related research issues.
• Supervises, mentors and trains new or junior research staff.
• 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.

Problem Solving

The incumbent decides how to best accomplish the daily requirements of the epidemiological studies, determines workload, prioritizes, delegates and establishes systems needed to achieve specific study goals. Efforts of multiple departments and disciplines must be coordinated to ensure the effective follow through of the studies and compliance of all involved. The incumbent functions independently under minimal supervision, following NIOSH, CDC, IRB and other regulatory agency guidelines and seeking council from the Principal Investigator as necessary. They also have responsibility to train, evaluate performance and make salary recommendations for support staff. They may participate in preparing the study budget by making salary and supply recommendations. This position makes independent decisions when overseeing and conducting details involved with studies; however, the development of protocols and procedures is a collaborative effort with the PI. Incumbents may act as an advocate for the particular studies to the public and agencies. The incumbent is often challenged to determine the most effective training needed for staff in order to ensure the most accurate information is being gathered. The development of new studies requires him/her to have an in-depth knowledge of scientific principles in order to recommend an alternative direction. The incumbent must be able to assess the most effective use of dollars and staff hours. He/she analyzes the potential benefits vs. allocation of assets. Another challenge is being able to respond with judgment and diplomacy to a patient’s request for information, as that may jeopardize the confidentiality of another participant or introduce bias into the study. The incumbent in this position assists in overseeing the activities of support staff members, collaborates research activities of research teams and participates in the administration of study budgets.

Work Environment and Level of Frequency that may be required:

Nearly Continuously: Office environment.

Often: Infectious disease, oils (there is air or skin exposure to oils or other cutting fluids), hazards (includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, or exposure to chemicals).

Physical Requirements and Level of Frequency that may be required:

Nearly Continuously: Hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking, standing, sitting.

Minimum Qualifications

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.

Preferences

• Bachelor’s degree in a health science or related field or equivalency; plus, 4 years professional research experience.
• A Master’s of Science degree in public health or related field.
• Working knowledge of computer systems and demonstrated human relation and effective communication skills.
• Experience in analytical methods to include qualitative and quantitative analysis of cross sectional, case-control, and cohort data.
• Knowledge regarding Center for Disease Control and Prevention (CDC), and Institutional Review Board (IRB).
• Experience conducting exhaustive literature searches and summarizing randomized controlled trials.
• Experience with best practice guideline construction.
• Knowledge of SAS and STATA statistical software programs and Endnote citation software.
• A strong epidemiological and statistical background is preferred.

Special Instructions Summary

Additional Information

The University is a participating employer with Utah Retirement Systems (“URS”). Eligible new hires with prior URS service, may elect to enroll in URS if they make the election before they become eligible for retirement (usually