Clinical Research Coordinator, Nurse Practitioner (CRC/Sub-I) - Kelly Science, Engineering, Technology & Telecom : Job Details

Position: Clinical Research Coordinator - Nurse Practitioner/Sub-I (Part-Time/Non-Exempt)

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.

Reports to: Medical Director/Site Manager

Job Description:

The CRC 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