VENESCO LLC
Junior Administrative Services Manager
VENESCO LLC, San Diego, California, United States, 92152
Job Description
Job Description Description: Junior Administrative Services Manager- Junior IRB Administrator The individual selected for this position will perform a variety of duties to support the Institutional Review Board at the Naval Health Research Center, San Diego, CA. Specifically, work efforts may include reviewing documents, drafting communications, maintaining records and documents and assisting with audits. Primary Responsibilities: a. Support the Naval Health Research Center IRB functions and HIPAA Privacy Office functions by reviewing all NHRC studies for compliance with DoD, Navy, and federal regulations and communicate needed changes to study teams for Exempt, Expedited, Full-Board (Initial, Continuing, and Modification) reviews including projects that are FDA-regulated. b. Draft formal approval letters, information-needed memos, emails, and other written communication according to site-specific, Navy, and DoD, and DHHS guidelines. c. Maintain IRB records and IRB meeting minutes to document compliance with relevant human subject protection regulations. d. Maintain document archives in electronic and paper format according to DoD regulations. e. Maintain training files and assist personnel with training requirements and technical assistance. f. Create and maintain tracking system for Not Human Subject Research determinations and Data Use Agreements. g. Assist with site audits as needed, in particular with HIPAA compliance. h. Demonstrate knowledge and understanding of the federal regulations on human research protection
Requirements: Basic Qualifications a. A minimum of a Bachelor’s Degree in life sciences or health psychology. b. A minimum of 5 years of Institutional Review Board (IRB) review experience or military medical R&D activities is required. c. A minimum 3 years of experience in reviewing and/or running R&D studies. d. Certification as a Certified IRB Professional (CIP), 2 years relevant experience can be submitted in lieu of CIP certification. e. Have a sound knowledge of medical terminology, clinical research processes, and IRB submission/filing guidelines. f. Strong skills to communicate effectively both orally and in writing; be able to communicate with a highly diverse group of people; possess effective organizational and analytical skills; must be highly organized and pay strong attention to detail and accuracy g. Ability to work independently and as a team member, in fact-paced, demanding, research environment in an effective and flexible manner h. Possess effective organizational and analytical skills. i. Proficient with Windows based computer systems including Microsoft Office. Desired Qualifications a. Previous or current clearance or history of a completed government background check
Job Description Description: Junior Administrative Services Manager- Junior IRB Administrator The individual selected for this position will perform a variety of duties to support the Institutional Review Board at the Naval Health Research Center, San Diego, CA. Specifically, work efforts may include reviewing documents, drafting communications, maintaining records and documents and assisting with audits. Primary Responsibilities: a. Support the Naval Health Research Center IRB functions and HIPAA Privacy Office functions by reviewing all NHRC studies for compliance with DoD, Navy, and federal regulations and communicate needed changes to study teams for Exempt, Expedited, Full-Board (Initial, Continuing, and Modification) reviews including projects that are FDA-regulated. b. Draft formal approval letters, information-needed memos, emails, and other written communication according to site-specific, Navy, and DoD, and DHHS guidelines. c. Maintain IRB records and IRB meeting minutes to document compliance with relevant human subject protection regulations. d. Maintain document archives in electronic and paper format according to DoD regulations. e. Maintain training files and assist personnel with training requirements and technical assistance. f. Create and maintain tracking system for Not Human Subject Research determinations and Data Use Agreements. g. Assist with site audits as needed, in particular with HIPAA compliance. h. Demonstrate knowledge and understanding of the federal regulations on human research protection
Requirements: Basic Qualifications a. A minimum of a Bachelor’s Degree in life sciences or health psychology. b. A minimum of 5 years of Institutional Review Board (IRB) review experience or military medical R&D activities is required. c. A minimum 3 years of experience in reviewing and/or running R&D studies. d. Certification as a Certified IRB Professional (CIP), 2 years relevant experience can be submitted in lieu of CIP certification. e. Have a sound knowledge of medical terminology, clinical research processes, and IRB submission/filing guidelines. f. Strong skills to communicate effectively both orally and in writing; be able to communicate with a highly diverse group of people; possess effective organizational and analytical skills; must be highly organized and pay strong attention to detail and accuracy g. Ability to work independently and as a team member, in fact-paced, demanding, research environment in an effective and flexible manner h. Possess effective organizational and analytical skills. i. Proficient with Windows based computer systems including Microsoft Office. Desired Qualifications a. Previous or current clearance or history of a completed government background check