What are the responsibilities and job description for the Clinical Research Coordinator II position at Actalent?
Job Title: Clinical Research Coordinator II
Job Description
The Clinical Research Coordinator II will plan, coordinate, evaluate, and perform the care of participants and collect data for assigned research projects under limited supervision. The CRC-II (Non-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 advocates for the patient while adhering to the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines.
Responsibilities
- Serve as a liaison between Principal Investigators and the Institutional Review Board (IRB) and the Office of Sponsored Programs (OSP).
- Prepare all documentation for clinical research purposes as required by Principal Investigators to track all submissions to IRB and OSP, and meet all reasonable deadlines for submission.
- Track all submissions to IRB and OSP, maintaining timely turnaround of all documents to avoid delays in study initiation and/or progress.
- Utilize positive interpersonal communication skills; communicate effectively with members of the healthcare team, patients, investigators, sponsors of research, and administration.
- Review all elements of the current institutional IRB approved informed consent (IC) document with study candidates and/or legal representatives, ensuring the rights, safety, and well-being of trial subjects.
- Manage multiple clinical trial protocols, coordinate the execution and follow-up of each protocol, utilize resources, and work independently; perform accurate, legible, and timely documentation.
- Manage records, study medication, and test articles in a confidential and secure manner.
- Promote Principal Investigator (PI) oversight by advising the PI, sub-investigator(s), Supervisor and/or Clinical Operations Manager of deviations in conduct, patient status, and issues relevant to the integrity of the trial and/or the safety of research subjects.
- Coordinate the work of support staff, laboratory technicians, and assistants to ensure efficient, timely, and high-quality results and adherence to research protocols.
- Collaborate with study sponsors and assist site monitors during their visits in a professional manner.
- Work flexible hours and be available as a resource for questions related to research projects.
- Perform other duties as assigned or directed to ensure smooth and efficient operations of the department.
Pay and Benefits
The pay range for this position is $62400.00 - $74880.00/yr.
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)
Nursing Clinical Ladder Program*
Sign-on Bonus*
Workplace Type
This is a fully onsite position in Tampa,FL.
Application Deadline
This position is anticipated to close on Mar 21, 2025.
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.
Salary : $62,400 - $74,880