Clinical Research Pharmacy Coordinator
We are currently searching for a Clinical Research Pharmacy Coordinator to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.
Duties & 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 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 Site pharmacist. Perform other assignments as required. Participate in site visits, as needed, to evaluate the facility, equipment, pharmacy personnel, and infrastructure capacity and provide report to federal client.
- Create workflows 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 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 the pharmacist.
- Work with 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 federal client.
- Edit, rewrite, and/or proofread drafts of materials prepared by pharmacists, as needed.
- Perform other assignments as required and/or assigned.
- 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 <795>, <797>, and <800>.
- 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 branch staff.
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.