Job Title: Clinical Research Coordinator II - UrologyJob Description The Clinical Research Coordinator II (Non-RN) is responsible for planning, coordinating, evaluating, and performing the care of participants while collecting data for assigned research projects. The CRC-II works under limited supervision and follows study-specific protocol guidelines. They communicate with Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead, and clinical research support staff. The role advocates for the patient while ensuring compliance with 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 necessary documentation for clinical research as required by Principal Investigators. + Track all submissions to IRB and OSP and maintain timely turnaround of documents to avoid delays in study initiation and progress. + Utilize positive interpersonal communication skills to effectively communicate with healthcare team members, patients, investigators, research sponsors, and administration. + Review elements of the current institutional IRB-approved informed consent document with study candidates and/or legal representatives. + Manage multiple clinical trial protocols, ensuring accurate, legible, and timely documentation. + Promote PI oversight by advising the PI, sub-investigators, and Clinical Operations Manager of any deviations in conduct, patient status, or issues relevant to trial integrity and subject safety. + Coordinate the work of support staff, laboratory technicians, and assistants to ensure efficient adherence to research protocols. + Collaborate with study sponsors and assist site monitors during their visits. + 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 expertise + Knowledge of GCP guidelines + Clinical study management Additional Skills & Qualifications + Ability to work independently in a fast-paced clinical or research environment + Strong interpersonal communication skills + Team-oriented with strong teamwork skills + Ability to perform multiple tasks efficiently under pressure + Specialized knowledge of the needs of patients in research trials, including device management trials + Critical thinking and analytical problem-solving abilities + Minimum of two to five years of experience in human life sciences/biomedical research + Understanding of standard clinical practices regarding informed consent and biospecimen collection + Proficiency with Microsoft Office applications (Word, Excel, Access, Outlook) + Bachelor’s Degree in Healthcare Administration, Research, or related field with 2 years of clinical research experience, or + Associates degree in Healthcare Administration, Research, or related field with 4 years of clinical research experience, or + Graduate of an accredited allied health certificate program with 6 years of clinical research or healthcare experience Work Environment The work environment involves working in a clinical or research setting. The role requires flexibility in working hours and the ability to handle multiple tasks efficiently under pressure. The coordinator must maintain confidentiality and secure management of study records, medication, and test articles. Positive interpersonal communication skills are essential for effective interaction with healthcare team members, patients, and research sponsors. 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 Orlando,FL. Application Deadline This position will be accepting applications until Jan 9, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.