Clinical Research Coordinator II

AdventHealth hires a Clinical Research Coordinator II to coordinate and oversee multiple clinical trial protocols, ensuring accurate documentation, patient advocacy, regulatory compliance, and trial integrity. The role collaborates with investigators, support staff, sponsors, and institutional partners throughout study start-up, execution, and closeout.

Responsibilities

Manages multiple clinical trial protocols, coordinates execution and follow-up, and performs accurate documentation

Promotes Principal Investigator oversight by advising on deviations, patient status, and trial integrity issues

Simultaneously executes and coordinate multiple clinical trials and function independently; perform diverse clinical and clerical duties

Other duties as assigned

Reviews informed consent documents with study candidates and ensures patient advocacy and informed consent throughout the trial

Coordinates support staff, laboratory technicians, and assistants to ensure efficient and high-quality results

Serves as a liaison between Principal Investigators, the Institutional Review Board, and the Office of Sponsored Programs

Prepares and reviews documentation for clinical research study start-up, execution, modification, renewal, and termination

Maintains current knowledge of regulatory requirements and implements changes as needed

Collaborates with study sponsors and assists site monitors during visits

Works flexible hours and is available for research project-related questions

Communicates effectively with healthcare team members, patients, investigators, sponsors, and administration

Manages records, study medication, and test articles confidentially and securely

Preferred

Bilingual (English/Spanish)

Cardiology experience

Certified Clinical Research Coordinator (CCRC)

Basic Life Support - CPR Cert (BLS)

Advanced Cardiac Life Support Cert (ACLS)

Bilingual English/Spanish

Cardiology Experience

CCRC Certification

BLS Certification

ACLS Certification

Benefits

Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance

Paid Time Off from Day One

403-B Retirement Plan

4 Weeks 100% Paid Parental Leave

Career Development

Whole Person Well-being Resources

Mental Health Resources and Support

Pet Benefits

Company

Multistate healthcare system providing whole-person care

Denver, US

https://networkofcare.adventhealth.com/colorado

10001+ employees

Qualifications

Ability to work independently in a fast-paced clinical or research environment

Interpersonal communication skills; ability to interact and maintain good relationships with a broad spectrum of healthcare disciplines and the public under all circumstances

Detail-oriented with teamwork skills; motivated, organized, and capable of performing multiple tasks in a timely manner, and working efficiently under pressure

Ability to simultaneously execute and coordinate multiple clinical trials and function independently; perform diverse clinical and clerical duties

Specialized knowledge of the unique needs of patients undergoing treatment in research trials including device management trials

Critical thinker with an analytical approach to problem-solving

Minimum of two to five years leveraging knowledge of human life sciences/biomedical research; physiological, cellular, biochemical, or molecular biology

Minimum two to five years understanding and leveraging standard clinical practices with regard to informed consent, biospecimen collection, and handling

Working knowledge of Microsoft Office applications, such as Word, Excel, Access, Outlook, and Internet knowledge and skill

Demonstrated proficiency in clinical study coordination across a spectrum of trial acuities

Knowledge of Federal regulations: Food and Drug Administration (FDA), Centers for Disease Control (CDC), Department of Health and Human Services (DHHS)

Bachelor's

2+ clinical research

Research experience including awareness of FDA / OHRP / ICH / GCP Guidelines and relevant state and federal regulatory/statutory guidelines

An equivalent combination of education ad relevant work experience may be considered in lieu of the stated degree requirement: - Bachelors degree and 2+ years of experience OR - Associates degree and 4+ years of experience OR - Technical/Vocational School and 6+ years of clinical research experience

Bilingual (English/Spanish)

Cardiology experience

Certified Clinical Research Coordinator (CCRC)

Basic Life Support - CPR Cert (BLS)

Advanced Cardiac Life Support Cert (ACLS)

An equivalent combination of education ad relevant work experience may be considered in lieu of the stated degree requirement: - Bachelors degree and 2+ years of experience OR - Associates degree and 4+ years of experience OR - Technical/Vocational School and 6+ years of clinical research experience.

Required skills

Clinical Research, Clinical Trial Coordination, Human Life Sciences and Biomedical Research, Physiological, Cellular, Biochemical, and Molecular Biology, Informed Consent, Biospecimen Collection and Handling, Microsoft Office, FDA Regulations, CDC Regulations, DHHS Regulations, OHRP Guidelines, ICH Guidelines, Clinical Practice (GCP), Cardiology, Certified Clinical Research Coordinator (CCRC)

Preferred skills

Bilingual (English/Spanish), Cardiology experience, Certified Clinical Research Coordinator (CCRC), Basic Life Support - CPR Cert (BLS), Advanced Cardiac Life Support Cert (ACLS)

Experience

2+ years