Clinical Research Coordinator II - Oncology

AdventHealth

Denver (CO)

On-site

USD 56,000 - 105,000

Full time

5 hours ago

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Time Off

403B Retirement Plan

Parental Leave

Career Development

Well-being Resources

Mental Health Resources

Pet Benefits

Job summary

AdventHealth in Denver, CO is seeking an experienced Clinical Research Coordinator to oversee multiple trial protocols, ensure regulatory compliance, and coordinate cross-functional teams. You will work with Principal Investigators, IRB, and sponsors to maintain trial integrity while managing documentation and start-up activities.

The role demands 2+ years in clinical research, familiarity with FDA/OHRP/ICH/GCP guidelines, and strong organizational skills.

Qualifications

Bachelor's degree required and 2+ years of clinical research experience.
Experience with FDA/OHRP/ICH/GCP guidelines and regulatory standards.
Familiarity with cardiology research is preferred.
CCRC, BLS, ACLS are preferred certifications.

Responsibilities

Manage multiple clinical trial protocols and documentation.
Coordinate execution and follow-up, ensuring trial integrity.
Advise on deviations and patient status with PI oversight.
Liaise between Principal Investigators, IRB, and S.O.P. offices.
Prepare study start-up, execution, modification, renewal and termination docs.
Collaborate with sponsors and site monitors; support regulatory compliance.
Maintain up-to-date regulatory knowledge and be flexible with hours.

Skills

Independent work

Interpersonal skills

Detail-oriented

Multitasking

Clinical trial coordination

Regulatory knowledge

Bilingual English/Spanish

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Our Promise To You

Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that

Our Promise To You

All the benefits and perks you need for you and your family:

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

Schedule

Full time

Shift

Day (United States of America)

Address

2525 S DOWNING ST

City

DENVER

State

Colorado

Postal Code

80210

Job Description

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. Detail oriented and has teamwork skills; motivated, organized, ability to perform multiple tasks in a timely manner, and work efficiently under pressure 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.

Knowledge, Skills, And Abilities

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)
Bilingual (English/Spanish) [Preferred]

Education

Bachelor's [Required]

Work Experience

2+ clinical research. [Required]
Cardiology experience [Preferred]
Research experience including awareness of FDA / OHRP / ICH / GCP Guidelines and relevant state and federal regulatory/statutory guidelines. [Required]

Additional Information

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.
Other certification as applicable to degree or program (i.e., medical assistant, medical technician, phlebotomy)

Licenses And Certifications