Clinical Research Coordinator

ARIZONA ARTHRITIS & RHEUMATOLOGY ASSOCIATES PC•Peoria, AZ

About The Position

Arizona Arthritis & Rheumatology Associates, P.C. (AARA), the largest private rheumatology practice in the United States, is seeking an ambitious, friendly, positive, and compassionate Clinical Research Coordinator. AARA has over 60 providers, 15 sites, and more than 350 employees. The Clinical Research Coordinator I reports to the Regional Manager and coordinates and implements assigned clinical research protocols in compliance with FDA CFR, GCP, and company SOPs. The role collects and records clinical research data, assists with patient assessments and scheduling, and maintains study files, supplies, and study medication accountability. The coordinator works on observational and clinical research trials, recruits and screens participants, supports study visits and assessments, maintains accurate study and regulatory records, and serves as a resource for research subjects and their families. The position also coordinates with physicians, employees, vendors, and sponsor monitors, and may take primary responsibility for implementing and managing new trials. Travel may be required for investigator meetings and other sites.

Requirements

Associate degree or equivalent.
In-depth knowledge of medical procedures and clinical terminology.
Strong organizational and communication skills.
Ability to develop and maintain strong professional relationships with providers and research subjects.
Excellent working knowledge of the clinical research industry, ICH-GCP Guidelines, and federal regulations regarding clinical research.
Ability to lift 20 pounds.

Responsibilities

Coordinate assigned observational and clinical research trials and meet study recruitment goals.
Maintain knowledge of active protocols and disease indications and provide protocol information to staff and patients.
Recruit and screen potential participants through chart review, outreach, referrals, and other recruitment efforts.
Keep the clinical trial management system updated with recruited subjects, completed visits, stipends, and accurate patient status.
Maintain chain of custody and accurate accountability for investigational products and devices.
Plan and perform protocol-required tasks, including informed consent, collecting medical histories and medication lists, phlebotomy, basic laboratory tests, lab processing and shipping, patient education, ECGs, questionnaires, assessments, vital signs, adverse event information, joint counts, data entry, query resolution, and study drug administration.
Track study supplies and reorder when necessary; schedule patient visits in appropriate electronic systems.
Document patient visits and communications in progress notes.
Triage adverse events, communicate adverse and serious adverse events to the research physician within 24 hours, and follow up with subjects as needed.
Provide educational information and consistent support to subjects and their families.
Complete required training documentation to ensure consistent implementation of protocols.
Assist with regulatory functions, including preparing IRB forms, processing updated informed consents and protocols, handling correspondence, and maintaining regulatory files.
Perform administrative filing for research participation, regulatory documents, lab results, receipts, invoices, and calibration reports.
Serve as a liaison among physicians, AARA employees, and third-party vendors.
Support sponsor monitoring visits, facilitate monitor access to the principal investigator, and ensure concerns are addressed promptly.
Maintain accurate delegation logs and ensure only delegated staff perform assigned study duties.
Ensure primary referring physicians receive timely progress notes about patient diagnosis and treatment.
May take primary responsibility for implementing and managing new clinical trials.
Perform duties according to established policies, procedures, regulatory and accreditation requirements, and professional standards.
Provide professional service to employees and research subjects.
Maintain office supply inventory and an organized office space.
Travel as necessary for investigator meetings and other sites.