Clinical Research Coordinator

Astera Cancer Care; Roseville (MI); On-site; USD 52,000 - 75,000; Full time

Job summary

The Cancer & Hematology Centers is seeking a Clinical Research Coordinator for the Roseville location. This role oversees day-to-day research trials, screens and consents patients, manages study drug inventory, and ensures FDA-compliant documentation and reporting.

You will coordinate with physicians, nurses, sponsors and lab staff, maintain trial databases, support adverse event reporting, and help with regulatory activities.

Qualifications

• Bachelor’s degree in health/biomedical sciences, health administration, biology or chemistry.
• Minimum 2 years of clinical oncology research experience.
• Working knowledge of regulatory documentation and FDA requirements.

Responsibilities

• Screen daily for potential patients and coordinate with physicians.
• Manage study drug and laboratory supplies for trials.
• Facilitate patient consent and education on available trials.
• Maintain data management and regulatory documentation.
• Coordinate with sponsors, sites, and clinical staff on trial progress.
• Support adverse event reporting and protocol compliance.

Skills

Research experience

Oncology research

Education

Bachelor’s degree in health/biomedical sciences

Job description

Our Mission: At The Cancer & Hematology Centers we are dedicated to help, healing and hope for cancer patients and their families.We provide our patients with advanced treatments, innovative research and, above all else, compassionate care. Our patients receive the most comprehensive, contemporary cancer care balanced with the compassion of a dedicated nursing and support staff. Treating cancer requires a team of committed and caring health care professionals working together to understand and address your needs. In addition to caring physicians, we have a full range of support staff available to assist you and your family, such as oncology-certified nurses, social workers, experienced lab and pharmacy personnel and a psychologist. Our focus is not just on healing but also on helping and offering hope. We know that being diagnosed with cancer is a life-changing event, and it takes a lot of adjustment to accept the emotional and physical realities of this disease. Our staff understands what you’re going through and can offer compassion and resources to help. To us, it’s important that healing isn't just centered on your disease site. Our cutting-edge cancer care is available close to home. Our medical staff have close ties to prominent hospitals and ongoing cancer research, and we bring those breakthrough advances to our regional centers to progress the level of care that is offered right here at home.Why Join Us? We are looking for talented and high-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.Job Description:Position Overview: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.*This is an additional Research position for the Roseville location due to expanding need for research efforts. The schedule is Monday to Friday working 7:30am to 4:00pm. No weekends or holidays.*Desired/Required Qualifications:Education:Bachelor’s degree in health/biomedical sciences, health administration, biology or chemistry, preferredSpecific skills & abilities:2 years research experience; clinical oncology research highly preferredWorking knowledge of medical and pharmaceutical terminology.Primary Duties and Responsibilities1. Screen daily for potential patients; communicate with physicians and other staff of potential and active patients. Responsible for managing study drug and laboratory supplies.2. 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.3. Ensure completion of all study-required assessments to include.4. Process, catalog and ship biologic samples to central laboratories as required by clinical trials.5. 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.6. Assist in the proper maintenance of current/pending regulatory documents in conjunction with regulatory coordinator. Assist in filing/organizing of clinical research essential documentation.7. Organize data systematically to allow for efficient and accurate clinical reports.8. 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.9. 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.10. Participates in on-going process improvement activities, making improvements in data management, and suggestions for programmatic improvements.11. 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.12. Participates in the audit process by preparing patient records and follow-up, as necessary.13. Function as a team member by expanding his/her responsibilities as directed by management to facilitate optimal workflow within the cancer center.14. 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.15. This employee has access to medical records. The parts of the medical record s/he needs to references to perform his/her job are as follows: Lab Information System, Pharmacy Information System, Entire Chart/Electronic Medical Record (EMR), Clinical Trial Management System (CTMS) and Electronic Billing System (EBS).#LI-Onsite