Team Lead-Clinical Research Regulatory

Job Requirements Position Summary Under the direction of the Operations Manager and Clinical Research Director, the Regulatory Lead is responsible for coordination of regulatory processes and activities. These include but are not limited to creating, submitting, and filing regulatory documents including serious adverse events, assisting Director and Managers with defined duties such as maintaining the electronic filing system, submitting documents to the IRB and creating and updating informed consents, and review and revision of departmental standard operating procedures.

The lead is expected to collaborate effectively within the Clinical Research department to promote regulatory readiness, provide specific guidance and assist in developing plans for adherence as needed. The Regulatory Leader is expected to support and engage in process improvement and to have knowledge and adhere to research institutional policies and research department standard operating procedures. The Regulatory Lead will assist Director and Managers with duties as assigned.

Minimum Requirements Education
• Bachelor's Degree Experience
• 3-5 years' experience in Clinical Research License/Registration/Certifications
• N/AP referred Requirements Preferred Education
• Advanced Degree

Preferred Experience
• Manager or Coordinator Experience Preferred License/Registration/Certifications
• Certification in research-related field required within 3 years of date of hire (CCRC, CCRP, CIP, RAP, etc.)Core

Job Responsibilities Membership in a Clinical Research Professional organization (ACRP, SoCRA, etc.) within 2 years of hire is recommended

Working knowledge, the Research Department processes and procedures related to research and regulatory FDA/OPRR/CCP/ICH guidelinesMS office experience/Access database

Attention to detail, excellent organizational skills.

Excellent knowledge of Good Clinical Practice Guidelines/Medical Terminology

Experience with writing and interpretation of Informed Consent Document Must have knowledge of Clinical Research Department guidelines, processes and policies

Must be meticulous and detail oriented. Must be self-directed, motivated and able to work independently

Regulatory lead must have knowledge of OHRP, FDA and Institutional Review Board guidelines, policies and processes

Must be able to withstand the stress and demands of an active position

Must be able to think clearly and quickly in high pressure/high volume environment

Must be able to work as a team member with staff, physicians, managers and administration

Must be able to effectively serve in a leadership role with the treatment/cancer control or regulatory team Ability to work other than scheduled hours with little or no notice as needed; ability to work independently with minimal direction and to be able to respond calmly and efficiently in crisis situation.

Possess excellent communication and organizational skills

Must be able to read, write, and speak English fluently; manual dexterity, good eye/hand coordination and adequate vision needed in daily work.

Job Summary Job number: P-108856

Profession:
Clinical Research Careers

Experience: