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Education and Compliance Coordinator - Pittsburgh, United States - University of Pittsburgh

University of Pittsburgh Pittsburgh, United States

1 month ago

Description

Education and Compliance Coordinator

The Education and Compliance Coordinator will be responsible for monitoring clinical research protocols associated with faculty held investigational drugs and devices and for conducting audits as needed. The Education and Compliance Coordinator will also be responsible for providing education to the research community. Involvement in educational events ranges from one-on-one training during provided through compliance reviews to presentations at seminars involving faculty, staff, and students.

Job duties include but will not be limited to:

Monitor clinical trials conducted under investigator-sponsored IND or IDE applications.
Perform quality improvement initiatives / compliance reviews of IRB approved protocols throughout the University and the UPMC.
Organize educational programs for the research community.
Maintain up-to-date information regarding federal regulations and ethical considerations, and IRB policies related to the use of human subjects in research.
Monitor informed consent as requested by the IRB Executive Committee or on randomly chosen protocols.
Assist with other Office of Research Protection (ORP) activities as needed.

BSN or MSN with prior human subject research experience in the biomedical field; CCRC certification through the Association of Clinical Research Professionals is desirable. Prior clinical experience with direct patient care preferred.

Job Summary

Serves as regulatory liaison for all clinical sites, coordinating centers, and data management centers and performs grant approval reviews and assists with regulatory reviews. Coordinates investigator training sessions, assists with compliance investigations, maintains databases, and develops approval guidelines to ensure institutional compliance with all regulations, policies, and applicable regulations.

Essential Functions

Computer skills, and excellent verbal and written communication skills.

Physical Effort

Walking for extended periods of time may be required on occasion when performing audits, throughout the University and UPMC HS.

The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.

The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.

Assignment Category: Full-time regular

Job Classification: Staff.Research Compliance Specialist II

Job Family: Compliance & Audit

Job Sub Family: Research Compliance

Campus: Pittsburgh

Minimum Education Level Required: Bachelor's Degree

Minimum Years of Experience Required: 2

Will this position accept substitution in lieu of education or experience: Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.

Work Schedule: Monday-Friday, 8:30 a.m.-5:00 p.m.

Work Arrangement: Monday-Friday, 8:30 a.m.-5:00 p.m.

Hiring Range: TBD Based Upon Qualifications

Relocation_Offered: No

Visa Sponsorship Provided: Yes

Background Check: For position finalists, employment with the University will require successful completion of a background check

Child Protection Clearances: The following PA Act 153 clearances and background checks are required prior to commencement of employment and as a condition of continued employment: PA State Police Criminal Record Check, FBI Criminal Record Check, PA Child Abuse History Clearance.

Required Documents: Resume, Cover Letter

Optional Documents: Not Applicable

Please see job description

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