Job Description
Job Description
Position: Clinical Research Coordinator - Nurse Practitioner (Full-Time/Exempt)
The Clinical Research Coordinator (CRC - NP) 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.
Reports to: Medical Director/Site Manager
Job Description:
The CRC(NP) 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
* Clients 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
Revised 4/21/2023
* 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 the client
* Communicates effectively and professionally with other team members in a timely manner
* Represents the client 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
For California Applicants:
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
Company DescriptionHere at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.
Our commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?
Company Description
Here at Medix, we are dedicated to providing workforce solutions to clients throughout multiple industries. We have been named among the Best and Brightest Companies to Work For in the Nation for two consecutive years. Medix has also been ranked as one of the fastest growing companies by Inc. Magazine.\r\n\r\nOur commitment to our core purpose of positively impacting 20,000 lives affects not only the way we interact with our clients and talent, but also with our co-workers! The goal is lofty, but it is made attainable through the hard work and dedication of our teams and their willingness to lock arms together. Are you ready to lock arms with us?