Clinical Research Coordinator

OneOncology•Roseville, MI

7d•Onsite

About The Position

The Cancer & Hematology Centers (CHC) is dedicated to providing help, healing, and hope to cancer patients and their families through advanced treatments, innovative research, and compassionate care. We offer comprehensive, contemporary cancer care with a dedicated team of professionals, including oncology-certified nurses, social workers, experienced lab and pharmacy personnel, and a psychologist. Our focus extends beyond healing to encompass support and hope, recognizing the life-changing impact of a cancer diagnosis. We bring breakthrough advances from prominent hospitals and ongoing research to our regional centers, ensuring cutting-edge care is accessible close to home. We are seeking talented and highly motivated individuals who are passionate about supporting the meaningful work of community oncologists and the patients we serve.

Requirements

2 years research experience
Clinical oncology research highly preferred
Working knowledge of medical and pharmaceutical terminology

Nice To Haves

Bachelor’s degree in health/biomedical sciences, health administration, biology or chemistry

Responsibilities

Responsible for the day-to-day functions of research clinical trials for CHC, including obtaining trials, screening and consenting patients, educating staff on available trials, data management, drug accountability, and regulatory document management.
Screen daily for potential patients and communicate with physicians and other staff regarding potential and active patients.
Manage study drug and laboratory supplies.
Serve as a liaison for enrolled clinical trial patients, addressing concerns, facilitating study treatment assessments, attending patient doctor visits, capturing and reporting adverse events, coordinating logistical requirements with physicians (e.g., radiology tests), and educating nursing staff on protocol requirements.
Ensure completion of all study-required assessments.
Process, catalog, and ship biologic samples to central laboratories as required by clinical trials.
Ensure clinical trial documentation from staff and investigational sites meets FDA requirements.
Assist investigators, field clinical staff, clinical research organizations, and sponsor companies in collecting data in a timely manner that meets protocol requirements.
Assist in the proper maintenance of current/pending regulatory documents in conjunction with the regulatory coordinator.
Assist in filing and organizing clinical research essential documentation.
Organize data systematically for efficient and accurate clinical reports.
Communicate via telephone/email with research sponsor companies on the status and progress of clinical trials, patient screening efforts, and enrollment.
Maintain the current status of research protocols, updating, amending, and interpreting as necessary, and communicate appropriate changes to the healthcare team.
Develop required materials for studies as directed, according to study guidelines and regulatory requirements, and facilitate the process of protocol approval/re-approval.
Maintain databases and systems for patient enrollment data, patient files, statistical data, and other information pertinent to studies.
Participate in ongoing process improvement activities, making improvements in data management and suggesting programmatic enhancements.
Manage and document incoming clinical trial payments and invoiceables.
Serve as a conduit between the Sponsor and the practice’s reimbursement department to ensure accurate and timely receipt of Sponsor payments, tracking payments to ensure they are in accordance with negotiated contracts and budgets.
Participate in the audit process by preparing patient records and follow-up as necessary.
Function as a team member by expanding responsibilities as directed by management to facilitate optimal workflow within the cancer center.
Communicate and interact with peers and other departments in a manner that positively affects patient services and CHC staff morale.
Interact effectively with patients/family members, demonstrating sensitivity regarding cultural diversity, age-specific needs, and confidentiality.
Access medical records, including the Lab Information System, Pharmacy Information System, Entire Chart/Electronic Medical Record (EMR), Clinical Trial Management System (CTMS), and Electronic Billing System (EBS) as needed to perform job duties.