"Regulatory Specialist-CCTO"

Position Summary

Under general direction, oversees the regulatory aspects of clinical trials from start-up through study closeout.

Job Responsibilities

• Coordinates designated protocol submissions for research projects. Prepares and submits necessary documents to the Protocol Review & Monitoring Committee (PRMC), the Institutional Review Board (IRB), and ancillary committees and departments.
• Above may include protocol applications, amendments, continuing reviews, serious adverse events (SAE) reports, protocol exception requests and other items as necessary.
• Works with research team to facilitate enrollment of research subjects in compliance with established regulations and guidelines. Reviews and confirms subject eligibility and regulatory compliance for enrollment. Submits eligibility exceptions to the IRB.
• Ensures maintenance of up-to-date regulatory records in compliance with established regulations and guidelines and internal SOPs.
• Prepares and negotiates consent forms and other subject facing documents with the sponsor and/or contract research organization (CRO) and internal entities, for externally sponsored studies.
• Prepares and submits all regulatory documents to sponsors and/or contract research organizations (CRO).
• Schedules and coordinates site initiation visits, regulatory monitoring visits, and assists with clinical trial audits or inspections.
• Maintains and disseminates accurate listings of active and potential studies to investigators and research teams.
• Provides regulatory assistance for specified investigator-initiated trials.
• Serves as the resource for detailed information on assigned protocols and other investigational research activities.
• Mentors and assists with the training on regulatory processes and procedures.
• Performs other job-related duties as assigned.

Education

• Bachelor's Degree

Experience

2+ years of prior clinical research experience in a healthcare setting or a Master's degree in regulatory affairs or similar.

Demonstrated knowledge and understanding of clinical research.

Knowledge of the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations and International Conference on Harmonization (ICH) Good Clinical Practice (GCP)

Knowledge, Skills and Abilities

• Excellent oral and written communication skills
• Demonstrated strong communication and interpersonal skills; demonstrated ability to interact with multiple constituencies and exercise 'people skills'.
• Demonstrated proficiency with MS Office Suite and database applications.
• Demonstrated organizational skills and ability to pay close attention to detail.
• Demonstrated critical thinking and analytical skills.
• Demonstrated ability to multi-task and prioritize in a fast-paced environment.
• Demonstrated ability to remain focus despite frequent interruptions.
• Ability to treat confidential information with utmost discretion.
• Demonstrated ability to exercise standards of professionalism, including appearance, presentation and demeanor.
• Demonstrated ability to work effectively in a collaborative manner with all departmental faculty and staff, as well as other institutional representatives.
• Ability to work independently and as part of a team within a fast-paced working environment.

Licenses and Certifications

• Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.