Actalent
Clinical Research Coordinator II - Urology
Actalent, Orlando, Florida, us, 32885
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 8, 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.
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 8, 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.