The Research Coordinator must be knowledgeable of standard research and oncology care practices. 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.
- Current BLS.
- Current Texas Registered Nursing License for RNs.
- Bachelor’s degree required for non-RNs.
- Oncology clinical trial experience preferred.
- Research Coordination experience preferred.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Essential and other important responsibilities and duties may include but are not limited to the following:
- 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 timeliness of protocol-related procedures.
- Collaborates with the PI, 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 and 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).
- 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 Nurse is a Registered Nurse, educates the patient and family regarding clinical condition, and/or disease process. If the Research Nurse is not a RN, he/she will schedule educational time with a RN.
- If the Research Nurse 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 Nurse is not a 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 return of such agents.
- 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 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 Nurse 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.
- Ensures 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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Requires full range of body motion including assisting patients, manual and finger dexterity, and eye-hand coordination.
- Requires standing and walking for extensive periods of time.
- Occasionally lifts and carries items weighing up to 40 lbs.
- Requires corrected vision and hearing to normal range.
The Research Coordinator reports to the Vice President of Clinical Operations.