Clinical Pharmacy Coordinator
We are currently searching for a Clinical 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 Bethesda, MD.
Duties & Responsibilities
- Support the dispensing of NIH investigational products for administration in clinical trials.
- Support NIH Investigational Product Management as oriented by the Pharmacist.
- Assist with providing pharmaceutical expertise and recommendations on pharmacy queries, product management issues, product availability during protocol conduct.
- Assist in the review of protocols and investigational brochures.
- Participate in site initiation visits, site qualifying visits, and protocol start-up meetings.
- Interact with physicians, nurses, outside sponsors, and other health professionals throughout the life cycle of the clinical trial to make needed adjustments to procedures and specifications as required per protocol and per federal regulations.
- Serve as a point of contact for Protocols and correspond with principal investigators, study coordinators, and sponsors.
- Schedule and participate in monitoring visits for protocols and answer any questions from auditor and monitor.
- Ensure that Investigational drug supplies for all protocols are obtained and maintained under the proper storage conditions and assist in preparing documents for temperature excursion reporting.
- Provide input on the pharmacy section of monitoring reports and provide responses to any issues noted.
- Provide input on the pharmacy monitoring section of Clinical Monitoring Plans, as requested.
- Assist in the preparation and implementation of pharmacy procedural set-up.
- Assist in the preparation of investigational drug information and documents which provide specific guidelines how to handle and dispense the investigational drug.
- Bachelor’s degree, preferably in Biological Sciences or Life Sciences is preferred but not required.
- Licensed pharmacy technician in a State, District of Columbia, or a territory of the United States is required.
- Minimum of three (3) years of experience working in a clinical trial pharmacy, Investigational Drug Service (IDS) Pharmacy preferred.
- Minimum of three (3) experience of experience providing research support and investigational drug management, including but not limited to: ordering, receiving, auditing, labeling, dispensing, and handling of investigational product returns.
- Experience with use of an electronic inventory system and IVRS/IWRS for drug accountability is preferred.
- Experience with pharmacy preparation for a GCP or FDA study audit is preferred.
- Analytical thinking and problem-solving skills to review and resolve monitoring and/or audit discrepancies or other pharmacy issues is required.
- Excellent working knowledge of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), standard pharmacy practices, including USP aseptic technique and USP hazardous drug handling is required.
- Excellent math skills to perform pharmaceutical calculations.
- Experience in the planning (site assessments, design, logistics), implementation, conduct, close-out, and oversight of clinical trials.
- Ability to work independently and as part of a team.
- Strong organizational skills.
- Excellent oral and written communication skills.
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.
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