Research Coordinator

Job Summary:

The Research Coordinator advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care. Research Coordinators assist with screening patients, schedule, and oversee all on-study requirements. Research Coordinators attend study teleconferences with sponsors and clinical research organizations to assure continuity of information.

Essential Duties and Responsibilities

Essential and other important responsibilities and duties may include but are not limited to the following:

Protocol Compliance

• Identifies primary and secondary study objectives and outcome measures

• Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research

• Complies with NEXT Oncology SOPs

• Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timelines of protocol-related procedures

• Collaborates with the Principal Investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs

• Provides protocol specific education to clinical staff

• Facilitates and participates in the preparation for an conduct of meetings/teleconferences with sponsors, monitors, and auditors

• Provides timely, accurate, and complete reporting of serious adverse events, unanticipated problems, deviations, violations, and noncompliance to the IRB and sponsor

• Contributes to the development of corrective and preventive action plans for unanticipated problems, deviations, violations, and issues of noncompliance

Informed Consent

• Identifies and intervenes to address barriers to effective informed consent discussions
  and decision making (e.g., literacy, capacity, language, distress, lack of time, therapeutic misconception)

• Describes and abides by institutional policy and processes for informed consent

• Ensures that the most current version of the IRB approved protocol consent document is used by the physician investigator when consenting or re-consenting a patient

• Collaborates with the physician investigator to ensure initial and ongoing consent process is performed and documented

• Assesses ongoing consent through discussions with patients and reinforcement of education

• Assesses patient’s understanding of the information provided during the informed consent process

• Ensures timely re-consenting as needed by the physician investigator

• Demonstrates understanding of tiered consent process when optional correlative studies
  (e.g., biospecimen, quality of life, patient-reported outcomes collections) are involved

• Confirms informed consent is obtained prior to performing any study specific tasks

Management of Clinical Trial Patients

• Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol

• Educates the patient and family regarding protocol participation

• Provides patient education regarding required study procedures

• If the Research Coordinator is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process. If the Research Coordinator is not a RN, he/she will schedule educational time with a RN

• If the Research Coordinator is a Registered Nurse, identifies patients who require increased nursing assessment and management in addition to the clinical trial requirements and collaborate with other members of the healthcare team to ensure patient safety. If the Research Coordinator is not an RN, he/she will schedule educational time with a RN

• Coordinates, schedules, and ensures timely completion of protocol-required events and other requirements (e.g., pharmacokinetics or –dynamics, scans, study visits, QOL,)

• Assesses individual patients for physical, psychosocial, and financial factors that could impact adherence with study requirements and implement interventions as necessary

• Evaluates patient’s adherence to and documentation of self-administered protocol agents and the return of such agents

• Collaborates with the investigator to determine disease response as defined by the protocol and communicates findings to the study team and other care providers

• Evaluates patient’s adherence to and documentation of self-administered protocol agents and re