Clincal Research Coordinator II

POSITION DESCRIPTION: The Clinical Research Coordinator II (CRC) reports to the Regional Research Manager 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. 

RESPONSIBILITIES:

• Responsible for the coordination of observational and interventional clinical research trials assigned
• Performance expectations will be assigned based on effort for each visit
• 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:
• Informed Consent
• Obtaining patient medical history and medication lists 
• Phlebotomy and basic laboratory tests
• Processing & shipping labs for central and local labs
• Patient education and training
• ECG
• Administer questionnaires and assessments
• Vital signs
• 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 events and serious adverse events within 24 hrs. Follow-up with the subject and collect required information.
• 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, employees, and third-party vendors.
• Participates in monitoring visits from sponsor provided appointees, ensures monitors can 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, procedures (SOPS), regulatory and accreditation requirements, federal and state regulations, good clinical practice, as well as applicable professional standards. 
• Provides all employees and research subjects with excellent service experience by consistently demonstrating professional decorum.
• Maintaining office supply inventory while keeping an organized office space.
• Travel as necessary for meetings and to assist other sites.

Qualifications:

• Bachelor’s degree or equivalent
• 1 year experience as a clinical research coordinator
• Must have in-depth knowledge of medical procedures and clinical terminology
• Possess strong organization and communication skills
• Ability to develop and maintain strong professional relationships with all providers and research subjects
• Excellent working knowledge of clinical research industry, ICH-GCP Guidelines and all federal regulations regarding clinical research.
• Ability to lift 20 pounds
• Willing and able to travel as needed to Rockville, White Oak and Frederick sites