Description:

The Clinical Research Coordinator II RN (CRC-II RN) serves under limited supervision, to plan, coordinate, evaluate and perform the nursing care of participants and collect data for assigned research projects. The CRC-II RN follows study specific protocol guidelines, communicates with Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead and clinical research support staff. The CRC-II RN 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.

Delivers safe care and demonstrates regard for the dignity and respect of all participants. Maintains adequate skills in clinical competencies including but not limited to physical assessment, phlebotomy and IV insertion. Practices the principles of Universal Precautions. Understands and abides by HIPAA regulations.

Maintains a clean, prepared clinical space. May perform set-up and turnover procedures in all clinical areas, per SOP’s, in a timely manner.

Participates in internal and/or external training programs to maintain licensure.

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. (Add from Chart)

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.

Skills:

Clinical research, oncology, Clinical trial, Chart review, Pre-screening patients, Data management, Edc

Top Skills Details:

Clinical research,oncology,Clinical trial,Chart review,Pre-screening patients

Additional Skills & Qualifications:

Ability to perform clinical tasks including assisting physician, ARNP and CRN with minor procedures and other study requirements within scope of practice.

Ability to acclimate and integrate into various clinical settings as needed per protocol

Demonstrated skills in clinical competencies including physical assessment, phlebotomy, IV insertion and administration of investigational drugs

Associate degree in Nursing

Minimum 2 years of Clinical Research experience

Current, active State of FL license as a Registered Nurse

BLS

Experience Level:

Intermediate Leve

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.