Clinical Research Coordinator - Oncology

Central Maine Healthcare is seeking a Full Time, Clinical Research Coordinator to join our Oncology Team!

Central Maine Healthcare is an integrated healthcare delivery system serving 400,000 people living in central, western and Midcoast Maine. CMH's hospital facilities include Central Maine Medical Center in Lewiston, Bridgton Hospital and Rumford Hospital. CMH also supports Central Maine Medical Group, a primary and specialty care practice organization. Other system services include the Central Maine Heart and Vascular Institute, a regional trauma program, LifeFlight of Maine's southern Maine base, the Central Maine Comprehensive Cancer Center and other high-quality clinical services.

If you are passionate about making a difference and are looking for your next great career opportunity, we look forward to reviewing your application!

Clinical trials provide critical information to assess the safety and efficacy of new pharmaceuticals and medical devices. Clinical trials are complex and highly regulated by federal and international regulations. By their very nature, they expose the research subjects to an undefined level of risk. The Clinical Research Coordinator (CRC) is a critical component of a clinical trial. A CRC conducts and facilitates the daily activities of a clinical trial and in coordination with the Principal Investigator has a primary responsibility to assure the safety and welfare of the research trial subjects. It is a specialized role that requires extensive training and clinical experience.

Essential Duties:

• Filing and office organization
• Patient/research participant scheduling
• Patient/research participant history
• Data collection
• Data entry
• Data management
• Follow-up care
• Laboratory procedures
• Order materials/supplies
• Schedule research meetings
• Comply with Institutional policies, SOPs and guidelines
• Must comply with federal, state, and sponsor policies
• Must possess knowledge of IRB and human subject protection and must adhere to an IRB approved protocol
• Expected to Perform all CRC responsibilities listed above
• Adhere to an IRB approved protocol
• Participate in the informed consent process of study subjects
• Support the safety of clinical research patients/research participants
• Coordinate protocol related research procedures, study visits, and follow-up care
• Screen, recruit and enroll patients/research participants
• Maintain study source documents
• Report adverse events
• Understand good clinical practice (GCP) and regulatory compliance
• Educate subjects and family on protocol, study intervention, study drug, etc.
• Comply with Institutional policies, standard operating procedures (SOPs) and guidelines
• Must comply with federal, state, and sponsor policies
• Manage essential regulatory documents as appropriate
• Complete case report forms (paper & electronic data capture) and address queries
• Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) as directed
• Collect, process and ship laboratory specimens

• Associates degree or a certification in an appropriate allied professional field.
• Certification in a medical discipline such as RM, LPN, CNA, PA, etc. is required. Although certification as a clinical research coordinator is not required upon entry into the position, failure to achieve certification within two (2) years may lead to termination.
• 1 year of previous clinical research experience. 

CMH actively promotes diversity in its workforce at all levels of the organization. We strive to create and maintain a setting where we celebrate cultural and other differences and consider them strengths of the organization. CMH is an equal opportunity workforce and no one shall discriminate against any individual with regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, genetic information or veteran status with respect to any offer, or term or condition, of employment. We make reasonable accommodations to the known physical and mental limitations of qualified individuals with disabilities.