Nurse Practitioner/Sub Investigator

Job Description

Job Description

Position: Nurse Practitioner/Sub Investigator (Full-Time/Exempt)

The Nurse Practitioner/Sub Investigator manages the daily operations of clinical trials. It is the responsibility of the Nurse Practitioner/Sub Investigator 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 Nurse Practitioner/Sub Investigator 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 included for the Nurse Practitioner include serving as sub-Investigator on studies and performing medical assessments on patients when delegated and appropriate.

Reports to: Medical Director/Site Manager

Job Description:

The Nurse Practitioner/Sub Investigator is responsible for the following operations, as well as other activities that may be necessary for successful completion of a research trial.

1. Training - Acquire and maintain the following Tekton-Sponsored

• Tekton Research, Inc. SOPs, processes, and policies – every year or as changes are made.
• Good Clinical Practice (GCP) – every 2 years
• IATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directed
• Participate in study-specific training as required
• Maintain medical license(s), certifications, etc.

2. Prepares the site for conduct of the study –assures site is prepared to conduct study.

• Attends Investigator’s meeting and Site Initiation Visit
• Trains staff who will be participating on the trial
• Creates or review source documents
• Works with Regulatory staff to obtain appropriate approvals
• Disseminates information to other personnel, as well as to potential patients
• Obtains all training and provide information for others to obtain training as needed
• Ensures site has obtained all required documents and equipment to conduct study
• Ensures site has received sponsor and IRB approval
• Communicates with the sponsor in a timely manner
• Communicates with others involved with/in the study, such as vendors, recruiting department and other resources, as assigned
• Ensures site receives Sponsor Greenlight prior to enrolling subjects

3. Manages study conduct- manages all aspects of preparation and conduct of assigned studies.

• Works with recruiter and office administrator to schedule appointments
• Works with Regulatory Specialist to schedule sponsor visits
• Prepares for each subject visit to ensure that all appropriate procedures are done, including obtaining initial and updated Informed Consents from each study subject
• Performs study-related procedures in accordance with protocol
• Ensures that all necessary data are gathered and recorded in the appropriate source documents
• Enters information into case report forms completely and accurately
• Communicates and work with sponsors and sponsor monitors
• Resolves data queries efficiently
• Ensures study documents are complete, current and filed correctly
• Manages laboratory procedures
• Manages study supplies
• Completes study closeout activities efficiently
• Performs phlebotomy and lab duties as needed

4. Nurse Practitioner

• Serves as Sub-Investigator on Trials
• Performs delegated medical procedures in accordance with protocol
• Other tasks as delegated by Medical Director

5. Serves as team member of Tekton

• Communicates effectively and professionally with other team members in a timely manner
• Represents Tekton in a professional manner
• Promotes harmony and professionalism within the workplace
• Completes assigned tasks accurately, efficiently, and timely
• Other duties as assigned.

Required Skills/Abilities:

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

Education and Experience:

• Nurse Practitioner Licensure

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