This individual will work under the supervision of the Principal Investigator (PI) and Director of the Non-Malignant Disease Transplant Program and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines, and RN License Scope of Practice.
Nursing duties by category
Principal Investigator Support:
- Complete protocol specific nursing assessments for study participants with appropriate documentation in the medical record.
- Monitor lab results and outside medical records. Communicate clinically significant events to the PI and triage as necessary.
- May act as sub-investigator when the principal investigator designates protocol specific responsibilities to the research nurse that are within the research nurse scope of practice.
- Identify trends in side effects and work with the principal investigator, the clinic nurse, and/or Transplant Team to develop and evaluate patient management strategies.
- Collaborate professionally and regularly with clinic nurse, to provide seamless patient care for research participants.
- Interact with staff at outside facilities to ensure continuity of care for research participants as well as ensure protocol requirements are met
- Coordinate with PI, Clinic Nurses, & Pharmacists to manage side effects/adverse effects of study drugs with either concurrent medications or sponsor supplied study drugs.
- Provide protocol specific nursing education to study participants, caregivers, and colleagues and engage in direct patient contact care and services, as appropriate.
- Fulfill requirements of UWMC Credentialing.
- Perform clinical procedures such as blood draws from central line catheters and peripheral sites; evaluation of skin in suspected graft vs. host disease including skin biopsies; and other procedures within RN scope of practice as necessary.
- Administer medications, including study drugs, biologicals, and radioisotopes (with radiation safety training), according to protocol and within RN scope of practice.
- Assess patient and monitor for side effects to study drug with appropriate response including administration of PRN medications per protocol direction and, as necessary, consultation with PI.
Clinical coordinator duties by category
Principal Investigator Support:
- Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
- Review study candidates’ medical records for study eligibility
Enrollment, Education & Protocol Implementation:
- Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
- Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
- Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
- Initiate scheduling of patient clinic visits, and on-going study visits. Ensure clinical procedures, lab test, and other protocol specific activities are completed as outlined in the protocols.
- Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
Budget & Billing, Other duties, etc:
- Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
- Work with internal partners to obtain and submit budget and billing information.
- Assist the Principal Investigator (PI) with protocol development, revision, and study analysis.
- Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
- Ensure study drug self-administration and accountability with patients.
- Perform non-clinical ECGs.
- Administer study questionnaires.
- Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies.
- Maintain or assist in maintaining IRB correspondence and regulatory documentation. Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports.
- Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
- Coordinate monitoring visits and respond to queries and other requests from study monitors.
- Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
- Participate in the review of charges for patients on clinical trials to ensure billing compliance.
- Travel for industry sponsored investigator meetings.
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations