About Company
Join Career.zycto and become an integral part of advancing oncology research. We are a dynamic and patient-focused clinical research organization dedicated to managing complex trials in the Flint area. Our collaborative environment empowers Clinical Research Coordinators to thrive, offering hands-on involvement with groundbreaking cancer treatments. If you’re passionate about making a tangible difference in patients’ lives through meticulous research, you’ll find an exceptional opportunity to grow and contribute significantly to our mission here.
Job Description
Career.zycto is seeking a highly motivated and detail-oriented Clinical Research Coordinator specializing in Oncology to join our dedicated team in the College Cultural Area of Flint, Michigan. This is a critical full-time role where you will play a pivotal part in advancing groundbreaking cancer research and directly impacting the lives of patients participating in clinical trials. As a CRC, you will be responsible for the meticulous coordination and administration of oncology clinical trials under the guidance of our Principal Investigators, ensuring strict adherence to study protocols, Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. Your expertise will contribute to the successful execution of trials from initiation through close-out, encompassing patient recruitment, data management, and ethical oversight. We are looking for someone with a passion for oncology, a commitment to scientific integrity, and an ability to navigate the complexities of clinical research with precision and compassion. If you are ready to apply your skills in a dynamic environment where your work directly contributes to new treatments, we encourage you to apply and help us make a difference in the fight against cancer.
Key Responsibilities
- Coordinate and manage assigned oncology clinical trials from study start-up to close-out in accordance with ICH-GCP guidelines, federal regulations, and institutional policies.
- Assist Principal Investigator with the informed consent process, ensuring participant comprehension and ethical conduct.
- Recruit, screen, and enroll eligible study participants according to protocol criteria and maintain enrollment logs.
- Schedule and coordinate participant visits, tests, and procedures as per study protocol requirements.
- Collect, record, and maintain accurate and complete source documentation and electronic data capture (EDC) for all study participants.
- Ensure accurate drug/device accountability logs are maintained and adherence to blinding procedures where applicable.
- Monitor participants for adverse events (AEs) and serious adverse events (SAEs), reporting them promptly to the Principal Investigator, Institutional Review Board (IRB), and sponsor as required.
- Prepare and submit regulatory documents to the IRB and other regulatory bodies, including amendments, annual reviews, and close-out reports.
- Act as a primary liaison between participants, physicians, internal staff, study sponsors, and contract research organizations (CROs).
- Assist with study audits and monitoring visits, providing necessary documentation and explanations.
- Maintain comprehensive study files, ensuring all regulatory and source documents are up-to-date, organized, and readily accessible.
- Educate patients and their families about the clinical trial process, specific study requirements, and potential benefits or risks.
- Participate in team meetings and contribute to continuous improvement initiatives within the clinical research department.
Required Skills
- Minimum of 2 years of experience as a Clinical Research Coordinator.
- Demonstrable experience in oncology clinical trials.
- Thorough understanding of ICH-GCP guidelines and FDA regulations.
- Proficiency in electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Exceptional organizational skills and meticulous attention to detail.
- Strong interpersonal and communication skills, both written and verbal.
- Ability to work independently and as part of a multidisciplinary team.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
Preferred Qualifications
- Bachelor's degree in a scientific or healthcare-related field (e.g., Nursing, Biology, Public Health).
- Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP).
- Experience with specific EMR systems such as Epic or Cerner.
- Phlebotomy skills and experience with sample processing.
- Familiarity with local IRB submission processes for the Flint area.
Perks & Benefits
- Comprehensive Health, Dental, and Vision insurance plans.
- Generous Paid Time Off (PTO) and paid holidays.
- 401(k) retirement plan with company matching contributions.
- Opportunities for professional development and continuing education.
- Life insurance and disability coverage.
- A supportive and collaborative work environment focused on impactful research.
- Direct contribution to advancing cancer treatments and improving patient outcomes.
How to Apply
To apply for the Clinical Research Coordinator – Oncology position, please submit your resume and a cover letter detailing your relevant experience and qualifications by clicking on the application link below. In your cover letter, highlight your experience with oncology trials and your understanding of GCP principles. We look forward to reviewing your application.
