Lead Clinical Research Coordinator - Beautiful Mid-Coast Maine

New England Cancer Specialists (NECS) is seeking a fulltime M-F Lead Clinical Research Coordinator in our Topsham, ME practice. The Clinical Research Coordinator will provide professional research and study services to our outpatient population in support of specific research protocols. The position will assist in the screening, recruiting, and treatment of volunteer subjects in accordance with all the study protocol and Good Clinical Practice (GCP) guidelines. This will include involvement in study and practice management, coordination with study sponsors and monitors, and maintaining regulatory documentation.

NECS is a private medical practice composed of 15 oncologists and hematologists serving the state and region from 5 different locations in Maine and New Hampshire. NECS is committed to achieving the best outcome and providing unmatched support in all areas for every patient. Nationally recognized as 1 of 12 Oncology Medical Homes in the nation and the first private practice to become a member of the Dana Farber Cancer Care Collaborative. NECS brings together top clinicians, researchers, and dedicated medical professionals, clinical and non-clinical to create the best possible experience for our patients.

Job Duties:

• Utilize current knowledge of GCP guidelines including the protection of human subjects to conduct clinical trials at the Practice.
• Oversee planning, scheduling, and implementation of day-to-day clinical activities and procedures as they relate to research protocols.
• Assist in recruiting, screening, enrollment, and retention of volunteer patients.
• Conduct patient informed consenting per GCP guidelines and document in the electronic health record.
• Ensure clinical activities are performed in accordance with the protocol and within clinical procedure safety standards.
• Monitor and record patient response to treatment and communicate study data and results in a timely manner. Maintain source documentation and oversee study activity reports to sponsors and medical, legal and regulatory bodies.
• Develop and coordinate maintenance of records on medication dispensation and usage during the course of the study
• Ensure the confidentiality of patient records and data per HIPAA compliance requirements.
• Prepare for all monitoring visits by ensuring that all documents are filed and organized as well as resolving all previous outstanding data queries or regulatory issues.
• Coordinate and prepare for institutional, sponsor, and internal audits.
• May oversee and guide the work of other nursing and/or support staff engaged in study activities.
• Perform miscellaneous, job-related activities as assigned.

Travel: Occasional travel to our Scarborough ME offices as necessary.

Please submit resume, cover letter, and salary requirements when applying