Job description
Schedule and Location
Full-time: Monday - Friday, Days
Cancer Center Building: 460 North Reading Road, Ephrata, PA 17522
Job Description
Under general supervision, coordinates clinical research activities and compliance to study requirements, patient and staff considerations relative to specific clinical trials and/or studies treatment, evaluation, support services and education for patients. Coordinates clinical documentation from referring and treating physicians for each patient. Monitors the clinical course and collection of research data for patients in clinical trials. Assists the medical investigators in achieving the objectives of clinical research studies and supports ongoing patient management approaches in the designated disease/treatment area(s). Considers nursing implications in areas of staff and patient educational needs, staff resources, and research objectives. Acts as a resource for clinical and support staff involved in the care of patients enrolled in appropriate studies. Coordinates and performs nursing responsibilities in specialty area(s) for clinical research patients.
Duties and Responsibilities
- Participates in the review of research protocols and assesses the appropriateness, feasibility and resource requirements for implementation. Develops plans as needed to address patient care and staffing requirements.
- Evaluates and identifies potentially eligible protocol patients and verifies according to protocol requirements. Provides direct patient education regarding protocol participation and provides additional information as appropriate. Ensures the integrity of the informed consent process and assists in obtaining informed consent from patients. Works with internal and external registration and scheduling personnel as appropriate to facilitate study entry.
- Introduces patient to the Health System and serves as a consistent contact for patient/family throughout the process of diagnosis and protocol treatment. Ensures that patient pretreatment, eligibility and informed consent documentation requirements are met prior to patient enrollment/registration in a research study. Registers and accomplishes randomization of patients enrolled in research studies. Documents record of institutional patient registration.
- Provides individualized information, support, and education regarding clinical trials. Maintains an excellent working knowledge of all protocols. Develops and conducts formal and informal education to inform clinical and other staff of implications of protocol procedures. Distributes protocol and patient information in a timely manner.
- Assists investigators in evaluating the quality of care and compliance to protocol requirements. Initiates corrective action as needed. Ensures that there is documented Institutional Review Board approval for protocols and consent forms prior to patient enrollment.
- Coordinates appointments for consultations and physician visits for protocol-related activities to ensure protocol compliance and optimal patient scheduling. Designs and compiles forms and educational materials to aid physicians and staff in complying with protocol requirements including tests and follow-up visits.
- Notifies Investigators and providers when patient is admitted to the Hospital and Follows patient via contact with inpatient nursing staff. Collaborates with nursing staff in assessing, planning, implementing, and evaluating the nursing care of the patient population specific to clinical research studies. Monitors dosage modifications and treatment calculations and assesses patients for toxicity and response.
- Participates in interdisciplinary meetings for patients.
- Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports.
- Maintains two-way communication with providers’ offices in order to improve the process of coordinating care for research patients.
- Reports outcome of research enrollment, as needed, to leadership for accreditation requirements.
- Identifies patient and/or provider needs and develops educational programs to meet those needs. Ensures delivery of quality services for patients.
- Collaborates with outreach/education coordinators for all service lines in the preparation and delivery of community and professional education programs.
- Coordinates, observes and/or records data for protocol therapy. Actively participates in assessing patients for toxicity and response using chart review and physical assessment skills and communication with physicians and nurses
- Adheres to all protocol requirements to ensure validity of clinical research patient data. Submits complete and accurate forms and materials to external agencies as required in accordance with protocol requirements. Monitors and facilitates necessary documentation in the conduct of clinical research studies. Regularly reviews protocol study forms for accuracy and compliance to protocol standards. Performs consistency checks, edits for errors, and monitors timeliness of data submission. Identifies system inadequacies and augments the system as necessary
- Serves as a resource to cancer support groups and other activities.
- Provides educational materials and ensure that they are coordinated, understandable, and meet the IRB standards.
- Protects patient confidentiality by promoting professional staff communications.
- Prepares and/or processes adverse event reports on protocol patients and submits these to the principal investigator and appropriate agencies. Alerts investigators and appropriate personnel of communications received regarding adverse events or drug reaction reports.
- Oversees the receipt, secure storage and dispensing of medications provided for protocol patients. Reviews investigational drug logs and inventories to assure that appropriate documentation is maintained, and federal guidelines are met.
- Coordinates all site visit audits. Gathers records and other necessary materials required for audits. Reviews records with all site visit teams and responds to audit reports in a timely manner.
Qualifications
- Minimum Experience:
- 3 - 5 years nursing experience
- Minimum Education:
- Bachelor's Degree
- Required Certification:
- Registration and current RN license in PA
- Preferred Certification:
- Certification in appropriate nursing specialty; National certification, clinical research/trials coordinator or clinical research associate (e.g., Association of Clinical Research Professionals)
Location: WellSpan Health · Oncology Research
Schedule: Full Time, Day, Monday-Friday
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