The Clinical Research Coordinator II (CRC) reports to the Director of Research and is responsible for coordinating and implementing assigned protocols in compliance with FDA CFR, GCP and company SOPs. The CRC collects and records clinical research data, assists in patient assessments, scheduling, maintain study files, study supplies and study medication accountability.
Responsible for up to 10 studies and expected to perform 20-40 visits a month.
Knowledge of all active protocols and disease indications within the company, and providing information about these protocols to staff and patients.
Responsible for the recruitment and screening of potential participants, which includes chart review of patients and schedules, contacting leads from outside recruitment efforts, and following up on referrals from all sources.
The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, hosting recruitment breakfasts, advertising when funds are available, referrals from rheumatologists and other AARA staff and may include attending health fairs and community outreach.
Keeping the clinical trial management system updated with newly recruited subjects, tracking completed visits and stipends for the participants and investigators, and ensuring status of each patient is accurate.
Responsible for chain of custody and accurate accountability of investigation product and devices.
Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following:
Obtaining patient medical history and medication lists
Phlebotomy and basic laboratory tests
Processing & shipping labs for central and local labs
Patient education and training
Administer questionnaires and assessments
Collect information for adverse event reporting
Assist with joint counts and other efficacy assessments
Data Entry and Query Resolution
Study drug administration, including injections
Tracking study supply inventory and reordering when necessary
Schedule patient visits in appropriate electronic systems
Documenting all patient visits and communications in progress notes
- Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events within 24 hrs. Follow-up with the subject and collaborate information as needed.
- Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program.
- Ensures uniform implementation of protocols by completing required training documentation in a consistent, accurate and timely manner.
- Assists in regulatory functions, including but not limited to preparing appropriate Institutional Review Board (IRB) forms, processing updated informed consents, protocols, correspondence, and regulatory filing in an accurate and timely manner.
- Responsible for administrative duties including filing documents related to subjects participation in research, regulatory, lab results, receipts, invoices, calibration reports, etc.
- Serves as a liaison to all physicians, AARA employees, and third party vendors.
- Participates in monitoring visits from sponsor provided appointees, ensures monitors are able to meet/speak with PI and ensures all concerns are addressed in a timely manner.
- Ensure the delegation logs are correct and only delegated site staff are performing duties as listed on the delegation log for any given study.
- Ensures that primary referring physicians receive timely progress notes on the patient’s diagnosis and treatment.
- May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner.
- Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards.
- Provides all employees and research subjects with an excellent service experience by consistently demonstrating professional decorum.
- Maintaining office supply inventory while keeping an organized office space.
- Travel as necessary for Investigator Meetings and other AARR sites.
- Bachelor’s Degree
1 year experience as a clinical research coordinator
Individual must have or be working towards obtaining Clinical Research Coordinator Certification (CRCC).
Must have in-depth knowledge of medical procedures and clinical terminology
Possess strong organizational skills
Ability to develop and maintain strong professional relationships with all providers and research subjects
Maintains confidentiality of patient and study information
Excellent working knowledge of ICH-GCP Guidelines and all Federal regulations
Understands and supports specific State regulations governing clinical research
Excellent verbal and written communication skills
Ability to lift 20 pounds
- Willing and able to travel for Investigator Meetings and other AARR sites