Nurse Practitioner-Sub-Investigator

About the role

Tekton Research is looking for an experienced Nurse Practitioner who is interested in clinical research to join our team in Austin, Texas. The Clinical Research Coordinator (CRC) manages the daily operations of clinical trials. It is the responsibility of the CRC to communicate with the investigator, sponsor and study participants all necessary information of the study and to conduct the study in accordance with the protocol. It is the responsibility of the CRC to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner. Additional responsibilities for the Nurse Practitioner include serving as sub-Investigator on studies and performing medical assessments on patients when delegated and appropriate.

Responsibilities

• Acquire and maintain Tekton-Sponsored SOPs, processes, and policies annually or as changes are made
• Maintain Good Clinical Practice (GCP) certification every 2 years
• Maintain IATA Shipment of Hazardous Goods certification (if applicable) every 3 years, or as directed
• Participate in study-specific training as required
• Maintain medical license(s), certifications, etc.
• Prepare the site for conduct of the study – assure site is prepared to conduct study
• Attend Investigator's meeting and Site Initiation Visit
• Train staff who will be participating on the trial
• Create or review source documents
• Work with Regulatory staff to obtain appropriate approvals
• Disseminate information to other personnel, as well as to potential patients
• Obtain all training and provide information for others to obtain training as needed
• Ensure site has obtained all required documents and equipment to conduct study
• Ensure site has received sponsor and IRB approval
• Communicate with the sponsor in a timely manner
• Communicate with others involved with the study, such as vendors, recruiting department and other resources, as assigned
• Ensure site receives Sponsor Greenlight prior to enrolling subjects
• Manage all aspects of preparation and conduct of assigned studies
• Work with recruiter and office administrator to schedule appointments
• Work with Regulatory Specialist to schedule sponsor visits
• Prepare for each subject visit to ensure that all appropriate procedures are done, including obtaining initial and updated Informed Consents from each study subject
• Perform study-related procedures in accordance with protocol
• Ensure that all necessary data are gathered and recorded in the appropriate source documents
• Enter information into case report forms completely and accurately
• Communicate and work with sponsors and sponsor monitors
• Resolve data queries efficiently
• Ensure study documents are complete, current and filed correctly
• Manage laboratory procedures
• Manage study supplies
• Complete study closeout activities efficiently
• Perform phlebotomy and lab duties as needed
• Serve as Sub-Investigator on Trials
• Perform delegated medical procedures in accordance with protocol
• Other tasks as delegated by Medical Director
• Communicate effectively and professionally with other team members in a timely manner
• Represent Tekton in a professional manner
• Promote harmony and professionalism within the workplace
• Complete assigned tasks accurately, efficiently, and timely
• Other duties as assigned

Qualifications

• MSN or DNP, or a current NP license, required
• Research experience preferred, but not required – ideally with GCP knowledge, EDC/CTMS familiarity, and strong clinical judgment
• Experience starting IVs, required
• Phlebotomy experience, required

Skills

• Ability to make sound medical judgement in relation to protocols
• Ability to assess safety measures in relation to protocols
• Demonstrated strong verbal and written communication skills
• Ability to work as a team member

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times