Clinical Research Coordinator - Axle

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)

• As a member of the Protocol Operations team, develop clinical research protocols and informed consents for evaluation of investigational vaccines and monoclonal antibodies, including but not limited to the following tasks: conduct background research on infectious diseases targets and any already developed, related countermeasures; review and interpret scientific data and technical information to include in the protocol as background and rationale; take on the primary responsibility of drafting the protocol and informed consent documents in close collaboration with the trial principal investigator (PI) and other members of the clinical research team; ensure compliance with regulatory requirements for clinical research and adherence to established protocol development timelines.  
• Distribute protocol and study documents to VRC personnel, scientific collaborators, and contractors from Clinical Research Organizations (CROs) per the work instructions of the Protocol Operations team.
• Draft protocol amendments, continuing reviews, and other protocol-related documents in close collaboration with the study PI, and with other clinical research team members, that are submitted to the IRB or FDA and facilitate review of these documents by the clinical research team.   
• Assist the clinical research team with responses to stipulations from the IRB. 
• Assist the clinical research team with responses to any correspondence and questions from the FDA related to clinical protocols. 
• Collaborate with staff of the VRC Regulatory Science and Strategy Program (RSSP) by contributing to the clinical research sections of investigational new drugs (IND) applications, investigational brochures, IND annual reports, and any other submissions to FDA requiring clinical research input. 
• Ensure that protocol-related data collection plan documents are consistent with regulatory requirements and the protocol objectives. 
• Gather, interpret, summarize, and/or graph clinical research research data included in protocols, IND applications, IND annual reports, investigator brochures or that are submitted for reporting to clinicaltrials.gov. 
• Assist with tracking the workflow of the Protocol Operations team to ensure timely development, completion, and submission of protocols and of all protocol-related documents. 
• Assist in processes for quality assurance and quality control of protocol and protocol- related documents, including at the time of their submission to the IRB. 
• Develop, update, and review work instructions (WIs) and standard operating procedures (SOPs) for the Protocol Operations team and implement contributions to and review of these documents by other team members of the Protocol Operations team. 
• Contribute to the development of Data Collection Forms (DCFs), electronic case report forms (eCRFs), and Reliance Agreements 
• Practice and facilitate adherence to SOPs, Good Clinical Practice (GCP), and Food and Drug Administration (FDA) regulations. 
• Demonstrate strong communication and collaboration skills with the Protocol Operations team and with other teams in the CTP or outside of the CTP. 

• Ph.D. and/or M.D. with at least one year experience in clinical research or in a related field. 

• Master's degree with at least 3 years of experience in clinical research or in a related field. 

• Prior experience managing a team preferred. 
   

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: careers@axleinfo.com

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.

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.