Clinical Research Coordinator

HCA Healthcare; Asheville (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) match

Education assistance

Paid time off

Tuition assistance

Life insurance

Job summary

Mission Health, part of HCA Healthcare, seeks a Clinical Research Coordinator to screen, enroll and monitor study subjects in a hospital setting, ensuring protocol compliance and data integrity.

Work with principal investigators, manage informed consent, assist sponsor and FDA audits, and maintain regulatory documents. A Bachelor’s degree is preferred; knowledge of GCP and clinical trials is essential.

Qualifications

• Bachelor’s Degree preferred; experience in lieu of education is considered.
• Knowledge of federal regulations, good clinical practices (GCP).
• Knowledge of medical and research terminology.
• Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel.
• Excellent Verbal and written communication skills.
• Excellent interpersonal skills.
• 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 pace environment with minimal supervision at off-site facilities.
• At least one year of experience as a Clinical Research Coordinator.

Responsibilities

• Screen and enroll patients for clinical trials according to protocol.
• Coordinate with principal investigator to meet enrollment targets.
• Verify informed consent and protocol adherence.
• Maintain source documentation and data entry into CRFs or EDC.
• Prepare and ship study materials and monitor supplies.
• Support sponsor and FDA audit activities.
• Prepare regulatory documentation and assist in site visits.
• Communicate progress and issues to the study team.

Skills

Communication skills

Regulatory knowledge

GCP knowledge

Data management

Team collaboration

Independent work

Clinical trial knowledge

MS Word

MS Excel

Education

Bachelor’s Degree preferred

Experience in lieu of education accepted

Tools

Clinical trial database

Electronic Data Capture (EDC)

MS Word

MS Excel

Job description

Do you have the career opportunities you want with your current employer? We have an exciting opportunity for you to join Mission Health which is part of the nation's leading provider of healthcare services, HCA Healthcare.

HCA Healthcare Research Institute is the multispecialty clinical research arm of HCA Healthcare. Our expert physicians work 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. Today's research paves the way for tomorrow's breakthroughs. Consider joining our HCA Healthcare Research Institute today!

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

Duties include but not limited to:

• Support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
• Responsible for working with the principal investigator to meet or exceed study enrollment.
• Review the study design and inclusion/exclusion criteria with physician and patient
• Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
• Ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
• Create study specific tools for source documentation when not provided by 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
• Responsible for completion of all required documentation according to site works guidelines
• Ensure timely and accurate data completion
• Maintain accurate and complete records including regulatory documents when applicable, 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 or asked to do so
• 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 escalates issues defined by Regional Site Manager

What qualifications you will need:

• Bachelor’s Degree preferred; experience in lieu of education is considered
• Knowledge of federal regulations, good clinical practices (GCP)
• Knowledge of medical and research terminology
• Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
• Excellent Verbal and written communication skills
• Excellent interpersonal skills
• 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 pace 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

Learn More About Employee Benefits

Note: Eligibility for benefits may vary by location.

"Bricks and mortar do not make a hospital. People do."- Dr. Thomas Frist, Sr.

HCA Healthcare Co-Founder

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.