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.
Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.
Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.
Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.
If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.
Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.