Clinical Research Coordinator

We have an exciting opportunity for you to join Mission Health, part of HCA Healthcare, the nation's leading provider of healthcare services. HCA Healthcare Research Institute is the multispecialty clinical research arm of HCA Healthcare. Our expert physicians collaborate with trusted pharmaceutical and biotechnology partners to unlock insights from real-world data and conduct clinical studies leading to breakthroughs in science, medicine, and care for all people.

About the role

As a Clinical Research Coordinator, your primary responsibility is to screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while subjects are on study. This role is hospital-based and involves comprehensive data collection, source documentation, completion of study-specific case report forms, and submission of adverse experience reports.

Responsibilities

• Support enrolling patients onto clinical trials through recruitment, screening, enrollment, and follow-up of eligible subjects according to protocol requirements.
• Work with the principal investigator to meet or exceed study enrollment goals.
• Review the study design and inclusion/exclusion criteria with the physician and patient.
• Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements and compliance.
• Ensure the integrity of data submitted on Case Report Forms or other data collection tools by careful source document review; monitor data for missing or implausible entries.
• Create study-specific tools for source documentation when not provided by the sponsor.
• Collect, complete, and enter data into study-specific 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.
• Ensure timely adherence to protocol requirements.
• Complete all required documentation according to site work guidelines.
• Ensure timely and accurate data completion.
• Maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs, and study-related communications.
• Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations.
• Communicate all protocol-related issues to appropriate study colleagues or manager.
• Attend study-specific on-site meetings, investigator meetings, conference calls, and monthly CRC meetings as required.
• Apprise the principal investigator, Research Operations Director, and Regional Site Manager of all study-specific medical issues for guidance.
• Assist sponsor and US FDA audit teams.
• Review and respond to any monitoring and auditing findings and escalate issues as defined by the Regional Site Manager.

Requirements

• Bachelor’s Degree preferred; experience in lieu of education is considered.
• 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 and the ability to communicate and work effectively with a diverse team of professionals.
• Organizational and prioritizing capabilities.
• The ability to work independently in a fast-paced environment with minimal supervision at off-site facilities.
• At least one year of experience as a Clinical Research Coordinator.

Benefits

Mission Health offers a total rewards package that supports the health, life, career, and retirement of our colleagues. The available plans and programs include:

• Comprehensive benefits for medical, prescription drug, dental, vision, behavioral health, and telemedicine services.
• Wellbeing support, including free counseling and referral services.
• Time away from work programs for paid time off, paid family leave, long- and short-term disability coverage, and leaves of absence.
• Savings and retirement resources, including a 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.
• Education support through tuition assistance, student loan assistance, certification support, dependent scholarships, and a partnership with Galen College of Nursing.
• Additional benefits for fertility and family building, adoption assistance, life insurance, supplemental health protection plans, auto and home insurance, legal counseling, identity theft protection, and consumer discounts.

Note: Eligibility for benefits may vary by location.