Purpose of the Position: Provide medical oversight and management of clinical trial participants, with supervision from research physician, while ensuring the integrity of the studies and the safety and well-being of the volunteer research participants. Perform relevant patient assessments and physical examinations; review inclusion/exclusion criteria and determine suitability of study volunteer for enrollment under the supervision of the research physician. Coordinates, directs and implements patient’s plan of care per protocol, including ordering, conducting and interpreting pertinent laboratory and diagnostic studies and procedures. Document findings per protocol, and maintain case report forms and other documentation as required by study protocols. Ensure protocols, Good Clinical Practices, applicable regulations and KRF Standard Operating Procedures are strictly followed.
Perform history, physical and assessments of patients per clinical trial protocols; review inclusion/exclusion criteria and determine suitability of study volunteer for enrollment under the supervision of the research physician. Order, conduct and interpret pertinent laboratory and diagnostic studies and procedures. Document findings per protocol.
Coordinates, directs and implements patient’s plan of care per protocol. Make medical recommendations and/or referrals. Call-in prescriptions, take blood pressure, temperature and pulse of patients. Dispense medications and evaluate patient progress through regular follow-up appointments. Facilitates patient education relation to medical processes, medication and health promotion.
Identify appropriate patients for enrollment in clinical trials and work with Clinical Trials staff to enroll patients in studies. Identify new trials appropriate for KSC patients, and collaborate with internal and external researchers to gain appropriate approval for patient participation.
Schedule /oversee study related visits to ensure protocol compliance. Assess and manage adverse events and/or any medical emergencies in conjunction with research physician.
Maintain case report forms and other documentation as required by study protocols and FDA; develop appropriate data collection, entry and reporting systems.
Ensure safety and well-being of all study volunteers/participants. Participate in safety assessments, as appropriate; contribute and participate actively in continuous quality improvement.
Review study protocols and serve as sub-investigator, when appropriate.
Collaborate with clinical trial monitors and Supervisor, Clinical Trials to ensure protocols, Good Clinical Practices, applicable regulations and KRF Standard Operating Procedures are strictly followed. Maintain confidential records of collected data, and ensure accuracy and integrity of data, including patient data and departmental programmatic data.
Acquires information on the most current developments and trends in the Nurse Practitioner field through education programs, professional associations and literature.
Attend investigator meetings with KSC physicians, as needed.
MSN as NP or MSN with completion of post-masters NP certification program or ARC-PA program graduation
1 – 2 years previous clinical and research experience
APRN-NP or PA with NCCP certification
BLS and ACLS
Willingness to obtain CCRC or equivalent within 2 years of hire
Patient Assessment, History and Physical
Word processing and spreadsheets
Highly effective verbal and written skills
If interested please apply online at www.kelsey-seybold.com