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We got a new job details in Vitalief & they are Hiring Candidates for Regulatory Compliance Program Coordinator
Company Name : Vitalief
Company Location : Newark, NJ
Job Position : Regulatory Compliance Program Coordinator
Job Category : Jobs in California
Job Description :
A fast-growing, innovative Clinical Trial Solutions Company, Vitalief is committed to identifying talented and passionate clinical research professionals to join our exceptional team as experts and active members of our clients’ research efforts.
We pride ourselves in fostering a culture of “people first” by hiring and retaining clinical research professionals as employees of Vitalief. We are a company that prioritizes personal and professional growth for OUR team. Although unconventional, we believe this to be the right approach and that our culture will attract and retain exceptional clinical research talent.
None of this is possible without the drive and passion of our Vitalief team members. If you are interested in the clinical research profession and being part of a culture that includes:
The ability to have a voice challenging the status quo with novel thinking
Flexible work environment
Investment in your career progression
Variable incentive/reward system
Encouraged and mentored by the talented Vitalief team to achieve full potential
Then we want to speak with you!
Note: Work is 100% on-site in Newark, New Jersey
Oversees all regulatory activities for the Clinical Research Unit and establishes priorities for workflow within the Department.
Review research proposals/protocols under which human subjects may be involved for conformity to Client policy and Institutional Review Board requirements and federal regulations.
Coordinate the protocol approval process with Committees, ensuring approvals are obtained and necessary documentation is on file prior to initiation of protocol.
Prepares and coordinates IRB submissions of protocol amendments, revisions, annual reports as required.
Acts as a liaison for investigators and other study staff with sponsor organization and pharmaceutical companies coordinating regulatory aspects of study.
Collaborates with the Director to develop, design and monitor standard operating procedures for regulatory affairs for all clinical protocols and training of all clinical and non-clinical research staff on Good Clinical Practice guidelines.
Review records with all site visit teams, FDA, NCI or other agents designated by sponsors (especially as related to appropriate consent, proper record keeping and quality assurance).
Participates in internal audits of investigator-initiated protocols as assigned and completes the appropriate audit checklists and submits to the Director for review.
Keeps abreast of all pertinent federal, state regulations and laws, and University policies as they presently exist and as they change or are modified.
Bachelor’s Degree in social science or related field.
1 to 2 years of regulatory affairs related experience.
Thorough working knowledge of regulatory requirements, Good Clinical Practices (GCP).
Experience with IRB submissions of protocol amendments, revisions, annual reports.
Excellent interpersonal, oral and written communication skills.
Strong organizational and administrative skills; detail oriented.
Solid computer skills (Microsoft Word and Excel)
Able to function independently and work flexible hours including weekends and evenings
Knowledge of Newark community.
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