Job Description

Job Title: Clinical Research Coordinator II - Urology

Job Description

The Clinical Research Coordinator II, under limited supervision, plans, coordinates, evaluates, and performs the care of participants while collecting data for assigned research projects. The CRC-II (Non-RN) follows study-specific protocol guidelines and communicates with Principal Investigators (PI), Sub-Investigators (Sub-I), Clinical Research Lead, and clinical research support staff. The CRC 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 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, meeting 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 to effectively communicate with healthcare team members, patients, investigators, sponsors of research, and administration.
• Review all elements of the current institutional IRB approved informed consent document with study candidates and/or legal representatives, ensuring patient advocacy and informed consent.
• Manage multiple clinical trial protocols, coordinate the execution and follow-up of each protocol, seek and utilize resources, and work independently.
• Perform accurate, legible, and timely documentation and manage records, study medication, and test articles confidentially and securely.
• Promote Principal Investigator (PI) oversight by advising the PI, sub-investigators, Supervisor, and/or Clinical Operations Manager of deviations in conduct, patient status, and issues relevant to the trial's integrity and 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.
• Prepare and/or review all required documentation for clinical research study start-up, execution, modification, renewal, and termination, meeting all reasonable deadlines for submission.
• Maintain timely turnaround of all documents to avoid delays in study initiation and/or progress and remain current on regulatory requirements and HIPAA regulations.
• 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 the smooth and efficient operations of the team and Core.

Essential Skills

• Chart review
• Pre-screening patients
• Consenting
• Data collection
• Clinical research
• Specialized knowledge in Urology
• Knowledge of GCP
• Clinical study management
• Informed consent processes

Additional Skills & Qualifications

• Bachelor’s Degree in Healthcare Administration, Research, or related field with 2 years of experience in clinical research, or Associates degree in Healthcare Administration, Research, or related field with 4 years of experience in clinical research, or Graduate of an accredited allied health certificate program with six (6) years of clinical research or healthcare experience
• Ability to work independently in a fast-paced clinical or research environment
• Organized with the ability to perform multiple tasks in a timely manner
• Ability to work efficiently under pressure
• Critical thinker with an analytical approach to problem-solving
• Minimum of two to five years of experience in human life sciences/biomedical research
• Understanding of standard clinical practices related to informed consent and biospecimen collection
• Proficiency in Microsoft Office applications (Word, Excel, Access, Outlook, Internet)

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 Dec 20, 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 actalentaccommodation@actalentservices.com for other accommodation options.

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