Description
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-Sponsored items:
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
Communicates effectively and professionally with other team members in a timely manner
Represents company 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
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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