Job Description

Job Title: Clinical Research Coordinator II - Urology Job Description The Clinical Research Coordinator (CRC-II), under limited supervision, will plan, coordinate, evaluate, and perform the care of participants and collect data for assigned research projects. The CRC-II 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 works to advocate 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 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. 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 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. Manage multiple clinical trial protocols, coordinate the execution and follow-up of each protocol, and perform accurate, legible, and timely documentation. 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. 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. Remain current on rapidly changing regulatory requirements and HIPAA regulations, implementing these changes as appropriate and in a timely manner. Work flexible hours and be available as a resource for questions related to research projects. Perform other duties as assigned to ensure smooth and efficient operations. Essential Skills Chart review Pre-screening patients Consenting Data collection Clinical research Urology GCP Additional Skills & Qualifications Bachelor's Degree in Healthcare Administration, Research, or a related field and 2-3 years of experience in clinical research or Associate's degree in Healthcare Administration, Research, or a related field and 4 years of experience in clinical research or a related field or Work Environment The work environment will require flexibility, with the ability to work independently and handle multiple tasks efficiently. The role involves collaboration with various healthcare disciplines and maintaining high standards of confidentiality and security for study records, medication, and test articles. The position demands adherence to hospital and departmental policies, local, state, and federal regulations, and the ability to adapt to rapidly changing regulatory requirements. Pay and Benefits The pay range for this position is $62400.00 - $74880.00 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) Workplace Type This is a fully onsite position in Kissimmee,FL 34747. Application Deadline This position will be accepting applications until Dec 21, 2024. 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 [email protected] (%[email protected]) for other accommodation options.

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