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
Experience
- 3-5 years'' experience in Clinical Research
License/Registration/Certifications
Preferred Requirements
Preferred Education
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 guidelines
- MS 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.