Clinical Research Coordinator II

AdventHealth

Celebration (FL)

On-site

USD 50,000 - 93,000

Full time

3 days ago
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Benefits offered by this job

Medical
Dental
Vision Insurance
Life Insurance
Disability Insurance
Paid Time Off from Day One
403-B
Retirement Plan
4 Weeks Paid Parental Leave
Career Development
Well-being Resources
Mental Health Resources

Job summary

AdventHealth in Celebration, FL seeks a Clinical Research Coordinator to manage multiple protocols, coordinate execution, and ensure accurate documentation. You will advise on deviations, patient status, and trial integrity while collaborating with investigators, IRB, and sponsors.

The role requires (2–5) years in clinical research, knowledge of FDA/OHRP/GCP guidelines, and strong organizational skills. Bilingual English/Spanish is preferred.

Qualifications

  • Ability to work independently in a fast-paced clinical or research environment.
  • Excellent interpersonal and written communication with diverse teams.
  • Attention to detail and the ability to manage multiple tasks under pressure.
  • Solid understanding of clinical study coordination and regulatory considerations.
  • Familiarity with FDA, OHRP, ICH, and GCP guidelines is preferred.
  • Bilingual in English/Spanish is preferred.

Responsibilities

  • Coordinate multiple clinical trial protocols from start-up through termination.
  • Advise on deviations, patient status, and trial integrity issues.
  • Review informed consent documents ensuring patient advocacy.
  • Collaborate with PI, IRB, and sponsor representatives for study oversight.
  • Prepare documentation for study start-up, execution, and renewals.
  • Maintain regulatory compliance and manage trial-related records securely.

Skills

Independence
Communication
Detail-oriented
Clinical research
FDA knowledge
Bilingual

Education

Bachelor's degree

Tools

MS 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 together we are even better.

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: 400 CELEBRATION PL City: CELEBRATION State: Florida Postal Code: 34747

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
  • Associates degree and 4+ years of experience
  • 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
  • Certified Clinical Research Coordinator (CCRC) [Preferred]
  • Basic Life Support - CPR Cert (BLS) [Preferred]
  • Advanced Cardiac Life Support Cert (ACLS) [Preferred]
Physical Requirements

Physical Requirements - https://tinyurl.com/msy4mja2

Pay Range

$49,795.20 - $92,622.40

Background Screening Requirement

Florida Law: Certain positions are subject to Florida Level 2 background screening, including fingerprinting, as required by state law. Applicants may review general information about Florida’s background screening requirements at the Florida Care Provider Background Screening Clearinghouse: https://info.flclearinghouse.com/

Equal Opportunity Employer

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

Every day, our fellow team members show up to work, unified by one shared mission: Extending the Healing Ministry of Jesus Christ. As a faith-based health care organization, our story is one of hope as we strive to heal and restore the body, mind and spirit. Though our facilities are spread across the country, this unwavering belief binds us together. Across every office, exam and patient room, we’re committed to providing individualized, holistic care. This is our Christian mission, and it inspires us to help make communities healthier and happier.

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