Clinical Advisor (PSTSS)

Concentric Methods is seeking a Clinical Advisor to join our team in Rockville, MD in support of the NIH.

Responsibilities:

• 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.
• Advise Branch management of merits and deficiencies in proposed studies.
• Develop protocol-specific training 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 DAIDS 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 DAIDS to pharmaceutical companies.
• Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability, and appropriate recommendations.
• 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.
• 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 PAB and DAIDS documents.
• Participate in program 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.