Clinical Regulatory Coordinator/ Specialist

Clinical Regulatory Coordinator/ Specialist

Contract

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Responsibilities:

• We are looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS).
• Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities. Act as a liaison between the Site IRBs and Clinical team to resolve regulatory queries and concerns.
• Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews. Oversee reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoot processes and procedures when issues are identified.
• Review documentation/submissions from departments outside of Regulatory Affairs. Develop training modules consistent with organizational needs in accordance with current international GCP requirements. Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. Create, review and revise all functional group SOP's. Maintain Trial Master Files.

Requirements:

• Demonstrate a working knowledge of internal SOP's, FDA/ICH guidelines to GCP's and regulatory compliance.
• Knowledge of and direct experience with Trial Master File and prior regulatory experience desirable. Fundamental knowledge of the conduct of clinical trials is preferred.
• Strong focus on teamwork, attention to detail, excellent organizational skills. Must have the ability to prioritize, and the ability to work in a multi-task environment. Must be able to work independently.
• Must maintain confidentiality of information, demonstrate good decision-making and judgment. Experience with Electronic Data Capture (EDC) such as Inform for clinical trials. Detail-oriented and comfortable with tight timelines. Experience with controlled clinical terminology is helpful but not required. Knowledge of and direct experience with Trial Master File and eTMF (e.g., Veeva) experience and Microsoft Office desirable.

Education:

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field. 0-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred.

All your information will be kept confidential according to EEO guidelines.