JOB TITLE: Clinical Trials Advanced Practice Provider
JOB SUMMARY: The Clinical Trials Advanced Practitioner will plan, direct, and evaluate oncology/hematology patient health care in ambulatory health services alongside provider colleagues and clinical trial staff; examine and treat chronic and acute episodic illnesses, order selected laboratory testing; offer referrals to physicians, write prescriptions, and perform office procedures within the scope of expertise, protocols, and available equipment.
The Clinical Trials Advanced Practitioner will provide research patient care as a delegated Sub-Investigator for clinical research studies conducted by Principal Investigator(s) at Nebraska Hematology-Oncology, PC., in accordance with study protocol, regulatory requirements, and standard operating procedures. The Clinical Trials APP will also collaborate with the research department in the overall coordination and conduct of clinical trials.
REPORTS TO: Clinical Director of Research
DUTIES/RESPONSIBILITIES: (This list may not include all of the duties assigned.)
- Should be knowledgeable in advanced health assessments and decision-making skill sets, prepared through a formal educational program that meets criteria established by the profession and is certified by examination by an approved certifying body.
- The APRN or PA-C works independently and in collaboration with physicians and other healthcare professionals to provide medical care to individuals receiving oncology treatments. Provision of care includes, but is not limited to: comprehensive assessment through history taking and physical examination; ordering, conducting, and interpreting diagnostic tests, prescription of pharmacological and non-pharmacological agents and treatments; identifying, developing, implementing, and evaluating a plan of care for patients; and providing hematology and oncology-specific teaching and counseling to patients, families, and groups.
- Sees ambulatory patients in the health services office for laboratory testing, examination, diagnosis, and treatment of chronic and acute episodic illnesses and minor injuries. Refers to physician as needed.
- Writes prescriptions and performs physical examinations and office procedures within the scope of expertise, protocols, and available equipment
- Coordinates referrals to support groups in subjects related to physical and emotional health (i.e., challenge of change, dealing with loss, dealing with chronic illness as caregiver, etc.). Coordinates health promotional activities (providing printed information, routine testing, flu shots, patient education, referral to genetic testing, etc.).
- Acts as a resource person for decisions, planning, and policies affecting the health of patients
- Collaborates with staff to identify patient needs and to help develop plan to meet these needs
- Read, understand and implement study protocols with accuracy and compliance
- Provide clinical trial-specific patient medical management as a Sub-Investigator, conducting subject visits on site with the research team as well as triaging study patient phone calls, walk-ins or need for add-on visits
- Review study patient procedure/medical results, develop plan of care in compliance with protocol and best medical practice, and communicate the care plan to patients and staff
- Collaborate with the Physician Investigator and research team to prescreen/identify new study candidates, review subject eligibility criteria and ensure protocol compliance with subject enrollment
- Perform study patient visit procedures which may include: informed consent, providing education/counseling the patient on protocol-specific requirements, ordering and facilitating study lab collection, performing study central lab packaging and shipment, ordering and facilitating investigational product/chemotherapy administration, randomizing subjects, dispensing/handling of study drug, directing scheduling of future patient visits, and ensuring the correct billing of study-reimbursed procedures vs. standard of care procedures.
- Perform study patient vital signs and EKG collection per protocol requirements
- Bridge protocol required and standard of care oncology/hematology subject medical management needs, and communicate with study sponsor medical team to preserve safe and high quality subject care management. Maintain as a primary point of contact for study patient and communicate subject status/needs with their care team.
Document medical care provided in the medical record/source documents/clinical trial management system for complete, accurate and contemporaneous data entry to sponsor electronic data capture systems
- Assess clinical trial participant adverse events for grade, relatedness, and seriousness and ensure compliance with protocol dose modification requirements
Assess clinical trial participant concomitant medications/procedures for compliance with protocol-specified allowed and/or prohibited medications
Report serious adverse events to sponsors within 24 hours of trial staff awareness and IRBs within required timeframes
Participate in new study feasibility-related discussions and tasks as needed by the clinical trial team
Attend study site initiation visits and complete study start up tasks as needed by the clinical trial team which may include: regulatory document submission, source document creation/review, creation of workflows and tools for conducting study-required cross-departmental procedures, developing and providing protocol-specific training for other delegated site staff
- Facilitate and perform continued reporting and communication with study sponsors and IRBs, and maintain organized study materials and files. Properly archive study files and communications
- Collaborate with outside vendors for scheduling of study patient procedures
- Assist the research team with data entry into sponsor-provided case report forms
- Assist in the creation, evaluation and maintenance of Standard Operating Procedures relating to research.
- Assure compliance of general and study specific processes with Standard Operating Procedures and applicable regulatory agencies.
- Perform other related duties incidental to the work described herein as requested by the Clinical Director of Research
PERFORMANCE REQUIREMENTS:
- Excellent verbal and written communication skills
- Excellent interpersonal skills
- Excellent organizational skills and attention to detail
Strong analytical and problem-solving skills
- Ability to prioritize multiple tasks based on urgency and significance
- Position will require interaction with patients, study sponsors, the research team, and principal investigators.
- Knowledge of organizational policies, regulations, and procedures to administer clinical research protocols.
- Knowledge of common safety hazards and precautions to establish a safe work environment.
- Ability to react calmly and effectively in emergency situations.
- Ability to interpret, adapt, and apply guidelines and procedures.
EDUCATION/EXPERIENCE:
- Clinical Research experience preferred.
- Graduate of an accredited Nurse Practitioner/Physician Assistant Program
- Medical Oncology experience preferred
Current clinical and professional experience including the ability to perform within the scope of practice for a Nurse Practitioner/Physician Assistant
- Master of Science
PHYSICAL REQUIREMENTS:
- Requires full range of motion including manual and finger dexterity and eye-hand coordination.
- Able to lift 10 pounds for routine performance of essential functions
- May be exposed to adverse indoor and outdoor environmental conditions, bloodborne pathogens, physical hazards (e.g., needle pricks, etc.) and chemical hazards
