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 ManagerJob 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.
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 yearsIATA Shipment of Hazardous Goods – (if applicable) every 3 years, or as directedParticipate in study-specific training as requiredMaintain 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 VisitTrains staff who will be participating on the trialCreates or review source documentsWorks with Regulatory staff to obtain appropriate approvalsDisseminates information to other personnel, as well as to potential patientsObtains all training and provide information for others to obtain training as neededEnsures site has obtained all required documents and equipment to conduct studyEnsures site has received sponsor and IRB approvalCommunicates with the sponsor in a timely mannerCommunicates with others involved with/in the study, such as vendors, recruiting department and other resources, as assignedEnsures site receives Sponsor Greenlight prior to enrolling subjects3.Manages study conduct- manages all aspects of preparation and conduct of assigned studies.Works with recruiter and office administrator to schedule appointmentsWorks with Regulatory Specialist to schedule sponsor visitsPrepares for each subject visit to ensure that all appropriate procedures are done, including obtaining initial and updated Informed Consents from each study subjectPerforms study-related procedures in accordance with protocolEnsures that all necessary data are gathered and recorded in the appropriate source documentsEnters information into case report forms completely and accuratelyCommunicates and work with sponsors and sponsor monitorsResolves data queries efficientlyEnsures study documents are complete, current and filed correctlyManages laboratory proceduresManages study suppliesCompletes study closeout activities efficientlyPerforms phlebotomy and lab duties as needed4.Nurse PractitionerServes as Sub-Investigator on TrialsPerforms delegated medical procedures in accordance with protocolOther tasks as delegated by Medical Director5.Serves as team memberCommunicates effectively and professionally with other team members in a timely mannerRepresents company in a professional mannerPromotes harmony and professionalism within the workplaceCompletes assigned tasks accurately, efficiently, and timelyOther duties as assignedRequired Skills/Abilities:Ability to make sound medical judgement in relation to protocolsAbility assess safety measures in relation to protocolsDemonstrated strong verbal and written communication skillsAbility to work as a team memberEducation 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
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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.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.