External Job Description:
Job Title: Nurse Practitioner or Physician Assistant
Work Set-Up: Working On-site
Scheduled Weekly Hours: per diem up to 20 h/week
Ensures safe and effective operations of clinical research studies.
Safeguards the wellbeing of research subjects in a medical capacity; reviews study protocols; plans and executes procedures in alignment with protocols and regulatory, health, and safety standards; raises or escalates study issues; clarifies protocols, inclusion/exclusion and research subject eligibility determinations; participates in the communication with clinical study volunteers and patients; and follows applicable regulations globally and by region.
Support study sites ensuring that studies are carried out according to protocol, standard operating procedures, GCP, and other applicable guidelines and regulations. This will be a part time 8-16 hours/week role, this is one day a week of your choosing and every other Saturday for at least 1 year. This will be directly working in the community in a mobile unit with a clinical study team recruiting and screening potential study participants.
Essential Functions
• Safeguard the well-being of the subjects in a medical capacity and ensure and maintain safety standards
• Maintain a safe environment in accordance with the Health and Safety policies.
Serves as sub-Investigator for clinical research studies conducted by a supervising principal investigator.
• Update and maintain skills, training and knowledge of current best nursing practice and topics related to clinical research.
• Act as volunteer advocate
• Deal with volunteer and visitor concerns in a pro-active manner and taking remedial action as required
• Assist staff, both registered and unregistered in Nursing Practices and the delivery of care to the volunteer
Report any deviation from normal practice to senior staff.
• Review of the study protocol, case report form (CRF), other study documents, and electronic data capture systems
• Participate in project meetings with the project team as needed.
• Clarifies protocols, inclusion/exclusion and research subject eligibility determinations
• Provide the medical assessment, interpretation and significance of various tests and procedures, including but not limited to Vital Signs, ECGs, telemetry, spirometry, Medical History, Physical Exam and laboratory test results.
• Plan logistical activity for procedures as per protocol
• Assist with the creation of volunteer instructions
• Helps identifying and obtaining required supplies and equipment
• Troubleshoot study issues
• Participate in huddles to ensure daily tasks are assigned to team members are executed to the expected standards
• Assist with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness.
• Support the recruitment of volunteers for inclusion in study based on pre-determined criteria.
• Orientate volunteers to the study and the unit including the purpose of the study, procedures and practical issues such as timelines for visits and restrictions on food and drink
• When applicable, responsible for the correct administration and custody of medicines according to company standard operating procedures.
• Perform a variety of complex clinical procedures on subjects including but not limited to Physical Exam, ECG, sample collection including phlebotomy, spirometry, vital signs, cannulation, and cardiac telemetry monitoring.
• Collect, record, and report clinical data and findings appropriately in case report forms (CRFs). Collaborate closely with study investigator informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol.
• Cooperate with study monitor and reserve sufficient time for questions during monitoring.
• Provide training to new staff members on study-specific topics and new clinical skills. Assist in ensuring compliance with staff training requirements by auditing and maintaining training records. Contribute to development of employees’ training and plans by advising team leads of continuing education requirements and opportunities
• Guidance and supervision of lower level staff to ensure processes are carried out in line with protocols and local SOP’s.
• Participate in quality and process improvement efforts to support control of unit budget, development of the facilities and services and the culture towards a high-performing and efficient team.
Qualifications:
• Other (APRN/NP) Nurse Practitioner or Physician Asst Required
• Ability to pay close attention to detail Advanced
• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced
•Current State RN license and Current NP or PA license/Certification in the state, country, or region in which the site resides Upon Hire Req
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