Manager, Research Credentialing and Regulatory Affairs - Hackensack Meridian Health

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Within the HMH Office of Research Administration, the Manager, Research Credentialing and Regulatory Affairs evaluates, analyzes, and coordinates all aspects of the credentialing processes for Principal Investigators and Sub-Investigators within HMH engaged in Human Subjects research. This role provides integral support to research operations by enabling timely verification of participating Investigators on clinical research protocols.

A day in the life of a Manager, Research Credentialing and Regulatory Affairs at Hackensack Meridian Health includes:

• Reviews and screens initial and continuation of applications for completeness, accuracy, and compliance with HSPP, AARPP and HNH guidelines, policies, and standards for human subjects research.
• Conducts primary source verification, collects and validates documents to ensure accuracy of all credentialing elements; assesses completeness of information and qualifications relative to credentialing standards and HMH criteria.
• Identifies, analyzes and resolves extraordinary information, discrepancies, time gaps and other idiosyncrasies that could adversely impact ability to credential investigators and begin research studies; discovers and conveys problems to HSPP Director and Manager for sound decision making in accordance with HSPP credentialing policies and procedures, including external regulations.
• Monitors files to ensure completeness and accuracy; reviews all file documentation for compliance with quality standards, accreditation requirements, and all other relevant policies; prepares and provides information to internal and external customers as appropriate.
• Enters, updates and maintains data from applications into credentialing database? (HURON?), focusing on accuracy and interpreting or adapting data to conform to defined data field uses, and in accordance with internal policies and procedures.
• Prepares, issues, electronically tracks and follows-up on appropriate verifications for efficient, high-volume processing of individual applications in accordance with applicable credentialing standards, established procedural guidelines, and strict timelines.
• Participates in the development and implementation of process improvements for the system-wide credentialing process.
• Communicates clearly with Investigators, their liaisons, research administration, as needed to provide timely responses upon request on day-to-day credentialing and issues as they arise.
• Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest developments to enhance understanding of various regulations and legislation of the health care industry that has impact on clinical research.
• Participates in approval of hiring and/or termination of team members.
• Establishes specific and measurable goals for employees and project teams for annual goal setting.
• Creates, reviews and recommends changes to Department policies and procedures.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Education, Knowledge, Skills and Abilities Required:

• Master's Degree in related field.
• 8 years of experience in Research regulatory.
• 2 years of experience in Clinical Research.
• Excellent written and verbal communication skills.
• Proficient computer skills including but not limited to Microsoft Office and Google Suite platforms.

Education, Knowledge, Skills and Abilities Preferred:

• Ability to interface effectively with multiple faculty, staff and stakeholders.
• Effective written and verbal communication skills; excellent interpersonal skills.
• Strong organizational skills with ability to coordinate activities across various departments, with strong attention to detail and ability to prioritize multiple tasks.
• Advanced computer skills in platforms such as, but not limited to, Microsoft Office Suite, Google, etc.; ability to learn new systems. 

Licenses and Certifications Preferred:

• Certification from approved regulatory and/or specialist training.

If you feel that the above description speaks directly to your strengths and capabilities, then please apply today!