Clinical Research Coordinator

HCA Healthcare•Asheville, NC

18d

About The Position

The Clinical Research Coordinator is responsible for screening, enrolling, and following study subjects while ensuring protocol compliance and close monitoring. The role handles data collection and source documentation, completes study-specific case report forms, and submits adverse experience reports. This is a hospital-based position supporting multispecialty clinical research conducted by HCA Healthcare Research Institute.

Requirements

At least one year of experience as a Clinical Research Coordinator.
Knowledge of federal regulations and Good Clinical Practices (GCP).
Knowledge of medical and research terminology.
Computer skills, including use of clinical trial databases, electronic data capture, and MS Word or Excel.
Excellent verbal and written communication skills.
Excellent interpersonal skills.
Ability to communicate and work effectively with a diverse team of professionals.
Organizational and prioritization capabilities.
Ability to work independently in a fast-paced environment with minimal supervision at off-site facilities.

Nice To Haves

Bachelor’s degree preferred; experience in lieu of education is considered.

Responsibilities

Recruit, screen, enroll, and follow eligible patients on clinical trials according to protocol requirements.
Work with the principal investigator to meet or exceed study enrollment goals.
Review study design and inclusion and exclusion criteria with physicians and patients.
Protect study participants by verifying informed consent procedures and adhering to protocol requirements.
Review source documents and monitor data for missing or implausible information to ensure the integrity of submitted data.
Create study-specific source documentation tools when not provided by the sponsor.
Collect, complete, and enter data into case report forms or electronic data capture systems.
Generate and track drug shipments, device shipments, and supplies as needed.
Report and follow up on serious adverse events as necessary.
Implement study-specific communications and ensure timely adherence to protocol requirements.
Complete required documentation according to site work guidelines and maintain accurate, complete study records, including regulatory documents when applicable.
Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
Communicate protocol-related issues to appropriate study colleagues or the manager.
Attend study-specific on-site and investigator meetings, conference calls, and monthly CRC meetings as required or requested.
Apprise the principal investigator, Research Operations Director, and Regional Site Manager of study-specific medical issues for guidance.
Assist sponsor and U.S. FDA audit teams.
Review and respond to monitoring and audit findings, and escalate issues as defined by the Regional Site Manager.

Benefits

Medical, prescription drug, dental, vision, behavioral health, and telemedicine coverage.
Wellbeing support, including free counseling and referral services.
Paid time off and paid family leave.
Long- and short-term disability coverage and leaves of absence.
401(k) plan with a 100% match on 3% to 9% of pay, based on years of service.
Employee Stock Purchase Plan.
Flexible spending accounts.
Preferred banking partnerships, retirement readiness tools, rollover support, and financial wellbeing counseling.
Tuition assistance, student loan assistance, certification support, dependent scholarships, and a partnership with Galen College of Nursing.
Fertility and family-building benefits and adoption assistance.
Life insurance and supplemental health protection plans.
Auto and home insurance, legal counseling, identity theft protection, and consumer discounts.