Kelly Services Clinical Research Coordinator I (CRC I) in North Las Vegas, Nevada

Clinical Research Coordinator I (CRC I), North Las Vegas, CA

Summary: The Research Coordinator position will coordinate the clinical research efforts of multiple investigators on multiple projects. This position will manage clinical trials and provide all aspects of protocol and project management. The Research Coordinator will use skills, knowledge and abilities to manage multiple studies and prioritize tasks involving multiple investigators.

Shift/Schedule: 20-30 hours/week.

6 month to 1 year contract with poossbile conversion.

Essential Duties and Responsibilities include the following:

  • Manages study start-up activities; oversee daily operations of research projects; consenting of participants; management of participants under the study protocols; and study closures.

  • Oversees the development of controlled clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies and VA.

  • Coordinates and creates a plan for the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.

  • Ensures appropriate transmission of clinical case data to the data management centers; reviews and addresses case report queries and problems, and clarifies and/or obtains changes to data as appropriate.

  • Completes, reviews, and maintains case report forms, source documents and regulatory binders for accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and initiates corrective action as required.

  • Screens and interviews potential study participants and makes the initial decision for further evaluations; schedules subject study visits and performs study procedures per sponsor protocol requirements and enters appropriate information into computerized patient record system. Develops appropriate recruiting ads using various sources, including but not limited newspapers, websites, educational institutions, etc.

  • Responsible for identifying and reporting any problems and/or issues in order to ensure all clinical aspects of studies are being carried out in accordance with state and federal regulations, guideline and policies.

  • Manages, oversees and maintains data collection methods and makes recommendations for improvement to ensure the highest degree of quality.

  • Supervises and trains research staff in the various research job functions (assessment, recruitment, study protocol, GCP, Local IRB, HRPP, R&D, etc.).

  • Determines participants eligibility for study by requesting, receiving, and recording medical data according to protocol; conducting patient assessment by interviewing and screening patients; and contacting referring physicians and abstracting medical reports. Ensure that all protocol requirements for study entry have been satisfied. Enter participant registration.

  • Monitors study participants while participants are on treatment phase of each protocol to ensure patient safety and adherence to study.

  • Gathers lab tests results, CT/MRI/bone scan/x-ray results, pathology/operative reports, discharge summaries, physicians notes, and outside medical records in order to extract patient data and record data in approved format for study purposes (e.g. case report forms, data summaries).

  • Initiates follow-up requests for data as necessary and assures comprehensiveness of individual participants data records.

  • Accesses, codes and reports toxicities/adverse events/protocol deviations to M.D., Clinical Trials Office (CTO), and Human Research Protection Program (HRPP) and ensures that toxicities are addressed and prevented through protocol-sanctioned dose modifications.

  • Independently researches and provides input on the development of new research protocols within the Division.

  • Under direction of Principal Investigator or responsible clinic, differentiates between adverse reactions directly related to investigational drugs and/or treatment as opposed to those unrelated to therapy under evaluation.

  • Monitors patient participation on study by tracking patient follow-up according to the requirements of specific research study, keeping physicians and other clinical staff apprised of data collection and reporting requirements, arranging and scheduling radiographic, laboratory, and clinical evaluations for study subjects, and identifying problems in execution of protocol and assisting physicians, nursing staff, and pharmacy staff in rectifying these problems.

  • Will meet with PIs on daily or weekly basis to keep PIs updated on all activities and report on project progress.

  • Establishes written protocols for all research activities for the research projects. Reviews documents, reports, and/or applications for omissions and inconsistencies.

  • Maintains program-specific data to track project milestones, progress reports, funding accomplishments, compliance strategies, etc.

  • Works closely with research participants to ensure the trial meets all regulatory requirements.

  • Works closely with the project administrator and other research coordinators to ensure all trials in the division are running smoothly, identified issues are addressed, and timelines are met.

  • Reviews project proposal or plan to determine time frame, funding limitations, procedures for accomplishing project, staffing requirements, and allotment of available resources to various phases of project.

  • Prepares project reports for management, client, or others.

  • Prepares and participates in audits conducted by sponsor/industry, national cooperative group or Clinical Trials Office.

  • Completes regulatory documents to Research and Development Committee and the Institutional Review Board to initiate new studies, modifications, investigative new drug safety reports, and patient adverse events.

  • Independently prepares written materials (reports, articles, journal articles, etc.) related to study data.

  • Confers with project personnel to provide technical advice and to resolve problems. Attends and participates in investigator directed study staff meetings.

  • Complies with safety and security policies and procedures.

  • Reports potentially unsafe conditions.

  • Coordinates project activities with activities of government regulatory or other governmental agencies.

  • Complies with safety and security policies and procedures.

  • Reports potentially unsafe conditions.

  • May perform additional duties.

Job Requirements:

  • Bachelor's degree (BA/BS)

  • Six mos. or more experience

  • Experience in a Hospital setting is preferred but not required.

  • Familiar w/ studies (DOD, NIH'S, DGP, VANPC, VAMC, VHA, etc.

  • Intermediate to Advanced knowledge of Microsoft Excel and Word software. Must be familiar with and able to work with other Microsoft Office software products such as Outlook and Access)

  • Exceptional organizational skills, attention to detail, a strong work ethic, and experience administratively managing clinical trial contracts.

  • Must be a self-starter and comfortable working in a fast-paced environment with high volume production requirements and meeting frequent deadlines under minimal supervision.

  • Ability to express thoughts in a clear, concise, and professional manner both verbally and in writing.

APPLY TODAY! Questions? Call Kevin at 602-548-1774 or email at kevin.lau@kellyscientific.com

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