Clinical Research Coordinator - NP

Tekton Research Inc•Irving, TX

17h

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

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
Nurse Practitioner Licensure

Responsibilities

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