Clinical Operations Manager PAB, OCSO, DAIDS
Camris International

Bethesda, Maryland

This job has expired.


Overview

CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!

We are seeking a Clinical Operations Manager to l provide services in support of the overall functions of the Office of Clinical Site Oversight, Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID) for the ACTIV2 clinical trial.

Responsibilities

• Independently work with pharmacists in the development and/or review of pharmacy specific documents (e.g. Pharmacy Establishment Plans) and standard operating procedures of relevance to Branch activities.
• Independently create and maintain a variety of electronic databases for all clinical research site pharmacy information and activities.
• Serve as an information resource on use of SharePoint applications and point of contact for resolving user problems.
• Independently create quarterly monitoring assignments based on pharmacy and protocol prioritization at clinical research sites for clinical site monitoring.
• Review site pharmacy monitoring reports and use the NIAID web-based clinical site monitoring system to address any issues noted with the site pharmacist until resolution.
• Create and track pharmacy special monitoring assignments.
• Manage a portfolio of sites in collaboration with a PAB Site pharmacist.
• Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report to PAB federal client.
• Create work flow and project management tools to track key milestones and/or identify potential problems associated with the review of Pharmacy Establishment Plans (PEPs) and complex protocols.
• Independently review and approve Pharmacy Establishment Plans. This includes interacting with outside stakeholders.
• Participate in Division meetings and assist the Branch with coverage for the HIV/AIDS Clinical Trials Networks' full group meetings and provide summaries as needed.
• Serve as a member of Branch and Office level working groups.
• Participate in protocol team or clinical research site conference calls with direction from PAB pharmacist.
• Work with PAB pharmacists in the development of protocol specific trainings for site pharmacists, which may include Power Point presentations and Manual of Operations.
• Develop, review and revise processes and procedures for Branch operations (e.g. SOPs, work instructions, guidance documents, etc.), in coordination with PAB federal client.
• Edit, rewrite, and/or proofread drafts of materials prepared by PAB pharmacists, as needed.
• Perform other assignments as required and/or assigned.

Qualifications

• Bachelor's degree in a health or science related discipline.
• Minimum of four (4) years of experience in clinical research or a related field.
• Certified Pharmacy Technician.
• Hospital pharmacy experience preferred; however, retail pharmacy experience considered
• Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters , , and
• Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection.
• Ability to work independently and display self-motivation in all aspects of work.
• Ability to function effectively and diplomatically as part of a team.
• Ability to identify issues that need special attention and bring those to PAB staff.

CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at CAMRIS.com . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.


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