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Clinical Advisor

3 months ago

Rockville, United States Axle Full time

(ID: 2024-5250)

**Benefits**:

- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:

- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)

**Overview**
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented **Clinical Advisor **to join our vibrant team at the National Institutes of Health (NIH), Division of Allergy, Immunology, and Transplantation (DAIT), Clinical Research Operations Program (CROP).
**Technical Requirements**:

- 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 logístical problems that may impede the conduct of a study.
- Develop the text for the study product 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 the study team and DAIT leadership regarding pharmacy aspects of proposed studies.
- Develop protocol specific trainings for site pharmacists and clinic staff utilizing web-based systems, software, or other tools (ie., power point presentation).
- Provide leadership in collaboration with DAIT Project Managers and Regulatory Officers for developing study-specific blind labeling and packaging plan and strategies.
- Review and approve study-specific labels by DAIT CPC.
- Write and review Study Specific Pharmacy Manuals in collaboration with Project Managers.
- Ensure that pharmaceutical concerns raised during the DCRC and other meetings are addressed in a timely manner.
- Advise the protocol team regarding pharmaceutical issues relating to DAIT/NIAID standards, FDA and other Health Authorities regulations, State and in-country requirements.
- Evaluate the protocol and provide leadership with estimates of study product needs and or cost 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.
- Provide pharmaceutical expertise during protocol conduct on pharmacy queries, product management issues, product availability and appropriate recommendations.
- Conduct site visits as required to obtain information about existing infrastructure and processes to use to evaluate pharmacy personnel and infrastructure capacity at production facilities and Clinical Research Sites, as well as for-cause site visits as needed.
- Review Pharmacy Establishment Plans with the site Pharmacist of Record and DAIT Project Managers to obtain information and clarity needed for final review and approval.
- Evaluate and finalize all temperature excursions that occur during shipment and at Research Pharmacy Sites in collaboration with Regulatory Officers.
- Receive and process product complaints with or without AES/SAEs from research site pharmacies.
- Write/draft Standard Operating Procedures (SOPs) related to DAIT Pharmaceutical Services and participate in SOP review committees as needed.
- Assist DAIT/ NIAID Clinical Product Center (CPC) Project Officer (PO)/ Contract Officer Representative (COR) in providing daily instructions, approvals for the CPC and other duties as needed for CPC oversight.
- Review and approve study-specific batch records submitted by DAIT CPC.
- Utilize pharmacy practice experience and pharmaceutical expertise in the design, review and revision of DAIT Pharmacy documents.
- Review pharmacy monitoring assessment reports and provide input regarding pharmacy and protocol prioritization for Clinical Site Monitoring plan as needed.
- Order, receive, ship to DAIT CPC and maintain chain of custody of Investigational Products (Ips) purchased by the DAIT Procurement Facility.
- Ensure proper storage conditions for IPs purchased by the procurement facility before they are transferred to DAIT CPC.
- Ensure orders received are properly reconciled in the FedMall in a timely fashion.
- Update the database of purchased IPs and track cost saving activities on a monthly basis.

**Specific Qualifications**:

- Doctor of Pharmacy degree (Pharm.D.) with accreditation as a registered pharmacist in one US state/juristication is required.
- Experience in investigational drug management, clinical research, protocol development and conduct, regulatory affairs (e.g., GMP manufacturing, IND filing, adverse events) and/or allergy or infectious diseses practice is required.
- Profeciency in MS Office including; Word, E