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About the Role

Tekton Research is seeking an experienced Nurse Practitioner interested in clinical research to join our team in Austin, Texas. This role involves serving as a Sub-Investigator on clinical trials, performing medical assessments, and managing daily trial operations.

Responsibilities

• Acquire and maintain Tekton-Sponsored SOPs, processes, and policies annually or as changes are made.
• Acquire and maintain Good Clinical Practice (GCP) knowledge every 2 years.
• Acquire and maintain IATA Shipment of Hazardous Goods knowledge every 3 years, if applicable.
• Participate in study-specific training as required.
• Maintain medical license(s) and certifications.
• Prepare the site for study conduct, ensuring readiness.
• Attend Investigator’s meetings and Site Initiation Visits.
• Train staff participating in trials.
• Create or review source documents.
• Work with Regulatory staff to obtain appropriate approvals.
• Disseminate information to other personnel and potential patients.
• Obtain all necessary training and provide information for others to obtain training.
• Ensure the site has all required documents and equipment for study conduct.
• Ensure the site has received sponsor and IRB approval.
• Communicate with the sponsor in a timely manner.
• Communicate with vendors, the recruiting department, and other assigned resources.
• Ensure the site receives Sponsor Greenlight before enrolling subjects.
• Manage all aspects of preparation and conduct of assigned studies.
• Schedule appointments with recruiters and office administrators.
• Schedule sponsor visits with the Regulatory Specialist.
• Prepare for each subject visit, ensuring all appropriate procedures are performed.
• Obtain initial and updated Informed Consents from each study subject.
• Perform study-related procedures in accordance with the protocol.
• Gather and record all necessary data in 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.
• Complete other tasks as delegated by the 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.
• Perform other duties as assigned.

Requirements

• Ability to make sound medical judgment 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.
• Experience starting IVs.
• Phlebotomy experience.

Skills

• GCP knowledge
• EDC familiarity
• CTMS familiarity
• Strong clinical judgment
• Phlebotomy

Location

• Austin, Texas

Work Type

• Part-Time

Experience Level

• Experienced

Education Level

• MSN or DNP
• Current NP license

About the Company

• Tekton Research is a clinical research organization.