Research Coordinator

Research Coordinator

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
• Collaborates with the investigator to determine if any treatment schedule or drug dose modification is necessary and communicates findings to the study team and other care providers
• Ensures appropriate communication between research and clinical staff related to patient-specific care needs
• Ensures evidence-based symptom management as permitted by the protocol

Documentation and Document Management

• Documents all patient encounters in the legal medical record per licensure and institutional requirements
• Obtains documents from outside providers or laboratories that are needed as part of the research data
• Educates other research team members and clinical staff regarding appropriate and accurate source documentation for patients of in clinical trials
• Assesses documentation or discrepancies and ensures that inaccurate or discrepant documentation is addressed in the medical record or other source documents
• Maintains the privacy and confidentiality of patients' source documents
• Maintains specified study documents in the Research Coordinator files
• Participates in the development of approved source documents, templates, or forms

Data Management and Information Technology

• Adheres to the data management plan per NEXT SOPs and sponsor data management plan
• Assists in troubleshooting data entry issues
• Ensures that relevant data from source documents are abstracted and entered into CRFs in a timely and accurate manner
• Ensure that data recorded on the CRFs can be verified within the source documents
• Participates in quality control activities to ensure data integrity, including timely responses to database or sponsor queries
• Enters data into electronic data capture for SAEs as appropriate

Required Education and Experience

• The Research Coordinator must be knowledgeable of standard research and oncology care practices
• Typically requires 5 or more years of experience
• Current Texas or Virginia Registered Nursing License for RNs
• Bachelor's degree required for non-RNs
• Oncology clinical trial experience preferred
• Research Coordination experience preferred