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 Protocol Coordinators to join our vibrant team at Rockville, MD.
- Recruit and screen patients for inclusion in protocols/clinical trials.
- Perform patient assessments and collect medical histories and physicals.
- Administer protocol consents and documentation.
- Monitor protocol compliance.
- Perform clinical data interpretation and data entry as needed.
- Oversee training and mentoring of staff.
- Evaluate and interpret protocol/clinical trial findings.
- Manage clinical protocols by training the study personnel; oversee compliance to protocol.
- Develop and adhere to relevant SOPs.
- Manage the quality control, completion and submission of study related documentation.
- Prepare, submit and maintain IRB, FDA, and/or other regulatory documents and research correspondence as needed.
- Monitor study enrollment goals and initiate strategies to promote enrollment and participant compliance.
- Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, and overseeing study visits, including collection and shipment of study samples, as needed.
- Obtain and document informed consent of participants.
- Assess acute and non-acute clinical and research related problems and toxicities, communicate to physicians and report adverse events per protocol to sponsor and IRB.
- Communicate on a day-to-day basis effectively with study site PI as well as study teams via regular meetings and telephone contact as needed.
Experience Required / Requirements
- Bachelor’s degree in nursing.
- Current state nursing licensure.
- Expertise in the fundamentals of clinical trials.
- Experience in clinical data management, database operations and analysis.
- Experience with IRB and FDA requirements.
- Certified in GCP and Human Subjects Protection training.
- Experience in clinical research setting with protocols and clinical trials.
- Strong diagnostic and clinical skills.
- Excellent writing skills.
- 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.