Our large Cardiology practice is seeking a Clinical Research Coordinator to join our Research Department in Manassas, VA.
We are looking for an energetic, hard work, out-going person to work in our very busy Cardiology office. We are a 'patient-centered' cardiology practice, working to provide exceptional care to our patients.
General Summary: A non-exempt, position responsible for providing administrative and technical assistance (collecting, processing, coordinating samples, specimens, information, and data). This position may serve as the clinic phlebotomist (depending on qualifications).
Essential Job Responsibilities:
1. Manage the front desk including subject reception/screening/scheduling.
2. Provide assistance to clinic staff by organizing files, projects, data, etc.
3. Provide general office management to keep operations running smoothly.
4. Assist with the development and execution of clinical research studies and programs
5. Work under specific instructions to assist with routine tests, experiments, and procedures
6. Collect, process, and assist in the compilation and verification of research data, samples, and/or specimens (following strict protocol and detailed instructions)
7. Enter data from forms and documents into databases and other documents
8. Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
9. Perform literature searches, research, and overall administrative assistance
10. Perform other duties as assigned
Education: Bachelor’s degree in health related field (1+ year clinical research experience preferred). Licensed in Virginia as an LPN or RN.
Experience: Associate's degree or equivalent required. At least one year experience in a healthcare setting. CPR certification required.
1. Support site selection, maintenance of clinical trial, and regulatory paperwork
2. Interact with CRA's and regulatory personnel
3. Track CRFs, drug labeling, monitoring reports, applications, etc.
4. Communication with monitors, vendors and study sites
5. Collection and review of study documents
1. Performs phlebotomy and specimen (blood/stool/urine/biopsy) processing/routing using universal precautions. Handles dry ice and ships specimens according to protocols daily.
2. Provides appropriate study-related education and updates to the applicable clinical staff in a timely manner.
3. Maintains current, accurate documentation including subject information, to research coordinator/PI as appropriate. Provides subject-specific reports for investigator review and signature. Transcribes data from source documents to case report forms.
4. Distributes, inventories, accounts for and returns clinical study medication/devices, lab kits, etc. per FDA regulations and Good Clinical Practices (GCPs) for handling clinical study materials.
1. Applies the research protocol for studies under direct supervision.
2. With the research coordinator, helps pre-screen potential subjects and help determine eligibility according to the study protocol. Maintains subject enrollment logs for research study.
3. Attends research-related meetings (e.g., site initiation meetings, monitor visits). Communicates as directed with sponsor and team. Completes sponsor-required duties in preparation for study monitor visits.
Work Environment: Position is in a well-lighted office environment. Occasional evening and weekend work.
Hours are Monday- Friday 8:30 am-5:00 pm.
Health, Dental, Vision, 401k and FSA benefits offered!
Resume and references