Located in Boston and the surrounding communities, Dana-Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow's physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.Functioning in a case management model, the Protocol Care Specialist provides specialized patient and resource scheduling and coordination for higher risk clinical services requiring significant knowledge of protocol-defined procedures, regulatory and financial compliance rules. Supporting adult and/or pediatric patients undergoing complex treatment plans and clinical research, the Protocol Care Specialist utilizes advanced knowledge of the clinical process for assigned protocols and/ or assigned treatment plans, patient populations, and disease areas to carry out scheduling and coordination services that require technical knowledge of care delivery systems, scheduling criteria, and FDA, FACT, NMDP and other regulatory agency rules. In every case, the Protocol Care Specialist serves as a key member of a multidisciplinary team of clinicians and other care coordination and technical experts and works closely with investigators, clinical research coordinators, cell processing, apheresis facilities, NMDP network centers, donor registries and nursing staff in a comprehensive case management model.
Responsible for effective and efficient scheduling of clinical trial or protocol patients and/or transplant donors for clinical services and other resources, including but not limited to exam and infusion clinics, donor services, donor network centers, apheresis facilities, cellular product laboratory processing, financial counselor support, care coordination, social work, nutrition, and other professional support services, operating room facilities, nursing support, admission to the hospital and associated beds;
As all patients or donors served by this job family shall be considered high risk or falling under highly regulated services, this job family is responsible for carrying out specialized tasks to support regulatory requirements and patient safety, requiring an understanding of the sequential processes involved in clinical trials and patient treatment plans that fall under specified regulatory controls;
Responsible for scheduling clinical trial or treatment plan formal protocol required tests and procedures, adhering to protocol schemas and for creating patient specific protocol calendars and flow sheets/templates;
Completes and submits all required documentation to determine clearance, eligibility and verification documentation as required by specified regulations;
Orders and ensures or carries out the shipping and tracking of lab tests or samples as required;
Carries out or supports patient education in person and/or by telephone, involving effective communication of complex steps of the protocol for care;
Participates in continuous training and maintains current knowledge of the clinical process, regulatory standards, and requirements that impact the assigned patient population to achieve patient safety, flow and resource utilization goals of the organization and sponsoring agencies;
Responsible for ensuring filing or reporting of certain documentation, including patient records, protocol records, quality control and quality assurance reports and the proper and timely posting of updates to the clinical scheduling systems and special databases as needed;
May lead or participate in the development of new scheduling systems or processes.
Unique to Cellular Therapies Track
Participates in routine case review meetings to represent patients and/or donors managed;
Maintains proficiency in operating multiple clinical information systems applications.
Unique to Clinical Research Track
Responsible for identifying and utilizing the correct billing scheme when scheduling donor testing and procedures;
Participates in disease program clinical research meetings;
Participates in the collection, maintenance, and reporting of data for internal and/or external data repositories as required.
Bachelors Degree required.
1-3 years relevant experience in a clinical scheduling or clinical trials support environment.
Demonstrated ability to work in highly regulated environments, such as clinical trials or complex medical systems.
Must be detail oriented with excellent verbal and written communication skills.
Ability to manage complex projects through to completion.
Proficient with Microsoft Office products and knowledge of electronic medical records system and GE_IDX preferred.
Ability to work independently, efficiently and effectively.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.
Dana-Farber Cancer Institute