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.
Requirements
- Identifies primary and secondary study objectives and outcome measures
- Adheres to applicable federal, state, and institutional regulations, policies, and procedures related to clinical research
- 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
- 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)
- 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
- Ensures timely re-consenting as needed by the physician investigator
- 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
- 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
- Ensures appropriate communication between research and clinical staff related to patient-specific care needs
- Ensures evidence-based symptom management as permitted by the protocol
- 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
- 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
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health and Welfare Benefits
- Bonuses and/or other forms of compensation
