Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking two (2) highly ambitious, adaptable, structured, and detail-oriented Clinical Advisors to join our vibrant team at Rockville, MD.
- Develop and adhere to relevant SOPs and pharmacy manuals.
- Review investigator brochures and conduct literature searches if needed to serve as subject matter expert regarding investigational products in ongoing research protocols.
- Oversee training and mentoring of staff.
- Manage the quality control, completion and submission of study related documentation.
- Prepare, submit and maintain Institutional Review Board (IRB), FDA, and/or other regulatory documents and research correspondence as needed.
- Monitor protocol compliance.
- Perform clinical data interpretation and data entry as needed.
- Answer questions regarding sterile compounding of investigational products.
- Establish cold-chain plans for transportation and storage of investigational products.
- Evaluate site pharmacies and give recommendations on their ability to meet protocol requirements for investigational product handling, storage, preparation, and dispensing.
Experience Required / Requirements
- PharmD or BS pharmacist (prior to 1992).
- Licensed to practice pharmacy in one of the US States or Territories.
- Completion of Good Clinical Practice (GCP) and Human Subjects Protection training and experience working in a GCP setting.
- Experience with FDA 21 CFR 312 regulations.
- Experience in a pharmacy practice setting working with sterile products and cold-chain of products.
- Experience in clinical research setting with protocols and clinical trials.
- Strong writing and recordkeeping skills.
- Knowledge of the roles and responsibilities of an investigational drug research pharmacist.
- Travel will be required, as much as 75% of the time across the United States and US Territories; length of travel: two weeks up to perhaps a month; depending on the need at the clinical site.
- Travel domestically among the 60 clinical sites in one year.
- Paid Time Off (PTO)
- 10 Paid Federal holidays
- Generous health coverage provided with no monthly premium to the employee
- Generous vision and dental coverage provided with no monthly premium to the employee
- Short and Long-Term Disability coverage (paid by company)
- Basic Life and AD&D coverage (paid by company; option to purchase additional coverage)
- 401(K) with significant company match & no vesting period
- Competitive salaries with performance bonus opportunities
- Discount plan for pet care, legal services, & identify theft protection
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.