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The Cancer & Hematology Centers · 9 hours ago

Clinical Research Coordinator

Norton Shores, MI

Full-time

Onsite

Entry, Mid Level

2+ years exp

The Cancer & Hematology Centers is dedicated to helping cancer patients through advanced treatments and compassionate care. The Clinical Research Coordinator is responsible for the day-to-day functions of research clinical trials, including patient screening, data management, and regulatory document management.

Health Care

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 ensure accurate invoiceables

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 and programmatic improvement activities

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 CHCWM staff morale. Interacts effectively with patients/family members and demonstrates sensitivity regarding cultural diversity, age specific needs and confidentiality

This employee has access to medical records. The parts of the medical record needed to perform this position is as follows: Lab Information System, Pharmacy Information System, Electronic Medical Record, Clinical Trial Management System, and Electronic Regulatory System

All other duties as assigned