| Position Summary: Rutgers, The State University of New Jersey is seeking a highly motivated Regulatory Affairs Manager for the Clinical Trials Office (CTO) within the Rutgers Institute of Translational Medicine and Science. The Regulatory Affairs Manager will provide technical assistance and support to the Rutgers Biomedical Health Sciences (RBHS) Clinical Trials Office (CTO) and the RBHS Scientific Advisory Board (SRB). The manager will serve as the CTO's regulatory liaison for interdepartmental and external agencies and will be responsible for coordinating the activities of the SRB. Will be responsible for evaluating the CTO's current standard operating procedures (SOPs) and implementing changes to improve and streamline these activities. The manager will also be the CTO's subject matter expert on FDA and DHHS regulations surrounding clinical research, Good Clinical Practice (GCP) guidelines, Clinicaltrials.gov requirements, submission and maintenance of Investigational New Drug (IND) applications, and submission of Institutional Biosafety Committee (IBC) applications. Among the key duties of this position are the following: - Serves as a resource for RBHS faculty and staff for all clinical research regulatory compliance activities.
- Serves as regulatory liaison for interdepartmental and external agencies including, but not limited to the Scientific Review Board (SRB), Institutional Biosafety Committee (IBC), Rutgers Biomedical Health Sciences (RBHS) IRB, Office of Human Research Protection (OHRP) and Food and Drug Administration (FDA).
- Coordinates administrative support to the SRB. This includes generation and distribution of materials prior to each SRB meeting, as well as, collection and collation of reviewer comments for the development of meeting minutes and dissemination of review and outcome to the study investigators.
- Develops, implements and evaluates Standard Operating Procedures (SOPs) for the CTO's regulatory compliance activities.
- Assists RBHS faculty in filing Investigational New Drug (IND) applications and exemptions with the FDA. Serves as a resource to faculty with regard to the requirements and develops a systems to track these submissions.
- Serves as a resource to RBHS faculty with regard to Institutional Biosafety Committee (IBC) requirements, and assists with applications, as requested.
Minimum Education and Experience: - Bachelor's Degree in related science plus a minimum of three (3) years' experience in regulatory affairs in an academic, pharmaceutical, or governmental setting, is required.
- Experience with growing clinical and research programs is essential as are demonstrated collaborative skills at multiple levels and a track record of strong, creative, entrepreneurial management and interpersonal leadership skills.
- Equivalent experience, education and/or training may be substituted for educational requirements.
Required Knowledge, Skills, and Abilities: - Demonstrate working knowledge of regulatory requirements.
- Demonstrated knowledge of how to accomplish superior performance in a unionized environment.
- Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
- Clear understanding of Food & Drug Administration (FDA), Office of Human Research Protection (OHRP), and Health Insurance Portability & Accountability Act (HIPPA) regulations, and possess a considerable understanding of Good Clinical Practice (GCP) guidelines.
- Extensive background in associated regulations governing clinical research.
- Strong understanding of policy and practice governing clinical research within a large institution.
- Strong communication skills (verbal and written).
- Ability to communicate complex information in English effectively both verbally and written to all levels of staff, management and external partners.
- Ability to work well with all levels of staff both within an organization, across functions, and across cultures; demonstrated ability to work effectively in cultures and environments other than one's own.
- Ability to meet or exceed customer service standards and expectations in assigned unit(s) and/or across multiple areas in a timely and respectful manner.
- Self-motivated, detail-oriented and capable of handling significant responsibility, as well as, shifting priorities; exercises discretion; takes initiative to resolve problems.
- Anticipates needs, responds quickly, provides guidance and support, monitors and follows up as required.
- Must have a passion for excellent customer service and commitment
Preferred Qualifications: - Experience with clinicaltrials.gov submissions.
Physical Demands and Work Environment: Posting Number: 21ST0256 Location: Downtown New Brunswick |
