Clinical Pharmacy Advisor
We are currently searching for a Clinical Pharmacy Advisor t 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
- Coordinate and oversee study products supply, packaging, distribution and accountability for all domestic and international clinical trials supported by the Division.
- Participate in the review, planning and implementation of clinical trials. This will include the evaluation of study design, feasibility, pharmaceutical regulatory requirements, and identifying solutions for pharmaceutical and logistical problems that may impede the conduct of a study.
- Develop the study intervention section of the protocols in cooperation with members of the protocol team and the pharmaceutical manufacturers for existing pharmaceutical products as well as new chemical entities and modalities. This includes researching and analyzing background material from Investigator’s Brochures, prescribing information and literature reviews.
- Oversee and manage quality assurance standards and standard operating procedures for all pharmacy and product issues.
- Advise Branch management of merits and deficiencies in proposed studies.
- Develop protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software or other tools.
- Write and review Operations and Study Specific Procedures manuals.
- Ensure that pharmaceutical concerns raised during the Scientific Review Committee meetings and by the Regulatory Support Contract are addressed in a timely manner.
- Advise the protocol team regarding pharmaceutical issues relating to program standards, FDA regulations and in-country requirements.
- Evaluate the protocol and provide leadership with estimates of study product needs based on factors such as sample size, dose, formulation, strength, rate of accrual, and duration.
- Perform calculations for study product dilutions and aliquots and for compounding pharmaceutical preparations.
- Generate Study Product Request Letter for leadership’s review and final signature. These letters are the official letters of request from the program to pharmaceutical companies
- Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
- Provide professional and technical assistance to pharmacists, study coordinators, investigators as well as domestic and international site personnel on a variety of topics, including protocols, study product preparation and dispensing information.
- Collaborate with protocol teams regarding communications and letters to site pharmacists during the entire conduct of a protocol.
- Conduct site visits to obtain information and create reports for federal staff to use to evaluate pharmacy personnel and infrastructure capacity at Clinical Research Sites.
- Establish standards for clinical site pharmacies, review and approve pharmacy plans required for the establishment of all clinical sites that participate in trials sponsored by NIH and other collaborators.
- Review Pharmacy Establishment Plans which include continuous communication with the site Pharmacist of Record to obtain information and clarity needed for final review and approval.
- Utilize pharmacy practice experience and pharmaceutical expertise in the review and revision of program documents.
- Participate in NIH funded clinical network meetings, face-to-face protocol development meetings, and protocol team meetings as a pharmaceutical subject matter expert.
- Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring (CSM).
- Contribute and edit scientific papers reporting results of research protocols for publication in scientific journals.
- Pharm.D. or B.S. degree from an accredited pharmacy school is required.
- Licensed/registered as a pharmacist in a U.S. state or territory is required.
- Completion of General Pharmacy Practice Residency or Specialized Residency or Fellowship plus one (1) year of clinical research experience or three (3) years of hospital pharmacy practice is required.
- Knowledge or proficiency with the implementation or utilization of USP Guidance Chapters, 795>, <797>, and <800> is required.
- Knowledge of Good Pharmacy Practice, Good Clinical Practice, and Human Subjects Protection is required.
- Excellent math skills in order to perform pharmaceutical calculations.
- Ability to work independently and display self-motivation in all aspects of work.
- Ability to function effectively and work diplomatically as part of a team.
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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