Clinical Research Coordinator - NP

Tekton Research Inc•Longmont, CO

1d•Onsite

About The Position

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 included for the Nurse Practitioner include serving as sub-Investigator on studies and performing medical assessments on patients when delegated and appropriate.

Requirements

Nurse Practitioner Licensure
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

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 every 3 years, or as directed (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 the trial.
Create or review source documents.
Work with Regulatory staff to obtain appropriate approvals.
Disseminate information to other personnel and potential patients.
Ensure the site has obtained all required documents and equipment.
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 prior to enrolling subjects.
Manage all aspects of preparation and conduct of assigned studies.
Work with recruiters and office administrators to schedule appointments.
Work with Regulatory Specialists to schedule sponsor visits.
Prepare for each subject visit, ensuring all appropriate procedures are performed, including obtaining Informed Consents.
Perform study-related procedures in accordance with the protocol.
Ensure all necessary data are gathered and recorded in 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.
Perform 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.