Clinical Research Coordinator

The Cancer & Hematology Centers•Grand Rapids, MI

9d•Onsite

About The Position

The Clinical Research Coordinator is responsible for the day-to-day functions of the research clinical trials for CHC. This includes obtaining trials, screening and consenting of patients, education of the staff on available trials, data management, drug accountability, as well as regulatory document management of the available clinical trials.

Requirements

Bachelor’s degree in health/biomedical sciences, health administration, biology or chemistry, preferred
2 years research experience
clinical oncology research highly preferred
Working knowledge of medical and pharmaceutical terminology.

Responsibilities

Screen daily for potential patients; communicate with physicians and other staff of potential and active patients.
Responsible for managing study drug and laboratory supplies.
Serve as a liaison for enrolled clinical trial patients to address patient concerns while on study and help facilitate study treatment assessments to include, attending patient doctor visits, capturing and reporting adverse events, coordinating logistical requirements with physicians (i.e. radiology tests), and educating nursing staff in 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 involved in research 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 the protocol requirements.
Assist in the proper maintenance of current/pending regulatory documents in conjunction with regulatory coordinator.
Assist in filing/organizing of clinical research essential documentation.
Organize data systematically to allow 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.
Maintains the current status of research protocols, updating, amending and interpreting as necessary and communicates appropriate changes to members of the health care team.
Develops required materials for study as directed according to study guidelines and regulatory requirements and facilitates process of protocol approval / re-approval.
Maintains database and system for patient enrollment data, patient files, statistical data and other information pertinent to studies.
Participates in on-going process improvement activities, making improvements in data management, and suggestions for programmatic improvements.
Manage/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.
Payments should be tracked to ensure they are in accordance with negotiated contract and budget.
Participates in the audit process by preparing patient records and follow-up, as necessary.
Function as a team member by expanding his/her responsibilities as directed by management to facilitate optimal workflow within the cancer center.
Communicates and interacts with peers and other departments in a manner that is viewed as having a positive effect on patient services and CHC staff morale.
Interacts effectively with patients/family members and demonstrates sensitivity in regards to cultural diversity, age specific needs and confidentiality.