Clinical Research Coordinator II Non-RN

4 weeks ago

Orlando, United States AdventHealth Full time

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

+ Benefits from Day One

+ Paid Days Off from Day One

+ Student Loan Repayment Program

+ Career Development

+ Whole Person Wellbeing Resources

+ Mental Health Resources and Support

+ Pet Insurance*

+ Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)

**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.

**Schedule:** Full-Time/Day

**Shift** : Monday-Friday

**The role you'll contribute:**

The Clinical Research Coordinator II (CRC II) serves the AdventHealth Research Institute (AHRI), under limited supervision, to plan, coordinate, evaluate and perform the nursing care of participants and collect data for assigned research projects. The CRC II follows study specific protocol guidelines, communicates with AHRI Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead and clinical research support staff. The CRC II works to advocate for the patient, while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines.

Works closely with AHRI Core managers to schedule clinical operations to facilitate the initiation and completion of clinical research studies, the CRC II also promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Lead and Director of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

**The value you'll bring to the team:**

+ Utilizes positive interpersonal communication skills; communicates effectively with members of the healthcare team, patients, investigators, sponsors of research and administration.

+ Reviews all elements of the current institutional IRB approved informed consent (IC) document, according to current FDA, state, federal and institutional regulations with study candidates and/or legal representative; ensures, through patient advocacy and informed consent as an ongoing process, that the rights, safety and well-being of trial subjects are the most important considerations and should prevail over the interests of science and society.

+ Manages multiple clinical trial protocols, coordinates the execution and follow-up of each protocol, seeks and utilizes resources and works independently; performs accurate, legible and timely documentation. Manages records, study medication and test articles in confidential and secure manner.

+ Promotes Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Supervisor and/or Clinical Operations Manager of deviations in conduct, patient status, issues relevant to the integrity of the trial and/or the safety of research subjects; abides by hospital and departmental policies and SOPs, as well as all applicable local, state, and federal regulations.

+ Coordinates the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high-quality results and adherence to research protocols.

+ Serves as liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP). Prepares and/or reviews all required documentation for clinical research study start up, execution, modification, renewal, and termination and will meet all reasonable deadlines for submission. Maintains timely turnaround of all documents to avoid delays in study initiation and/or progress. Remains current on rapidly changing regulatory requirements and HIPAA regulations and implements these changes as appropriate and in a timely manner.

Qualifications

**The expertise and experiences you'll need to succeed:**

+ Bachelor's Degree and 2 years of experience in clinical research **or**

+ Associates degree and 4 years of experience in clinical research or related field **or**

+ Graduate of an accredited allied health certificate program with six (6) years of clinical research or healthcare experience.

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.

**Category:** Research

**Organization:** AdventHealth Orlando

**Schedule:** Full-time

**Shift:** 1 - Day

**Req ID:** 24015827

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.

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