The Senior Protocol Coordinator will serve as a senior lead coordinator in the recruitment, assessment, treatment, data collection and follow-up for patients enrolled in a research study. The direct patient load of the senior protocol coordinator would be limited to allow engagement in other more expanded activities such as training and education of other protocol coordinators, oversight of research operations at LAC-USC in coordination with CISO management, coordination of research activities related to cellular therapy.
Generate or update protocol specific order sets for the Clinical Trial Unit
Manage and coordinate operational processes and procedures related to clinical trials involving cellular therapy; this would include the creation and maintenance of processes and SOPs to schedule patients, perform research procedures, coordinate with the various involved entities such as transplant team, inpatient oncology team, and others
Serve as the CISO lead for minority accrual and outreach activities (overseeing Elena Nieves); Develop and expand outreach to improve recruitment of minorities
Maintain and update curriculum/modules for education and training.Â Trains and on-boards new employees and provide continuous education for existing staff.
Assist with managing CISO research operations at LAC+USC
Serves as a senior lead in the recruitment, assessment, treatment, data collection and follow-up for patients enrolled in a research study or studies. Provide guidance to research coordinators to plan, organize and schedule activities to meet research study objectives. Critiques in-house research studies prior to implementation. Implements multiple research studies.
Attends start-up meetings for new industry trials off site. Attends on site study initiation meetings with sponsor and entire research team after IRB approval to discuss protocol and identify potential problems and resolutions.
Provides leadership, guidance, and direction to other health research personnel. Demonstrates techniques or procedures to others. Provides input to performance appraisals.
Determines patient eligibility for a research study and assesses patients for eligibility for a protocol. Conducts thorough pre-study assessment to determine baseline toxicities. Explains study to patients and potential patients. Answers patientâs questions regarding study, drug toxicities and effectiveness. Educates patient regarding possible toxicities and instructs patients to call if questions or problems. Ensures that written informed consent is obtained, readable and that risks are described accurately based on experience. Completes protocol specific data management forms to aid in protocol compliance.
Reviews research schedules for studies and informs principal investigator if there is concern that a test or the timing is inappropriate. Schedules required tests and procedures and follows through on completion and return of results. Corresponds with any outside physicians to ensure protocols are followed and that tests and procedures are performed. Obtains appropriate treatment records from hospital or physician and obtains outside laboratory results.
Ensures safe administration of investigational drugs. Works with pharmacists and hospital nurses to ensure that protocol agents are administered accurately and safely and the maintenance of accurate drug records.
Monitors patientâs status throughout the study. Reviews and evaluates health status, lab findings and reactions. Assesses patients for adverse effects of treatment based on knowledge of the patientâs disease and clinical status, which includes recognizing unusual or unexpected side effects that may represent delayed or cumulative toxicity. Monitors any deviation that may occur and are instrumental in seeing that amendments are made to the study, so that the integrity of the study is not compromised.
Serves as a consultant to the principal investigator. Discusses patient eligibility questions and any patient concerns. Notifies physician of serious adverse events. Discusses toxicities, protocol deviations or violations that may require a protocol revision. Reviews patient response to therapy. Informs other health team members regarding patientâs response to treatment and/or medications, adherence to protocolâs schedule, need to reevaluate treatment and specific medical concerns and personal assessment. Generates data for ongoing evaluation of study, as requested.
Ensures study toxicities are recorded correctly and accurately. Follows FDA guidelines for prompt reporting. Communicates serious adverse events to the IRB, government, sponsors, outside agencies and coworkers. Communicates any patient related problems or concerns to staff nurses, social workers, and home health coordinators.
Develops systems and procedures to complete requirements of the protocols. Resolves inconsistencies in the protocols. Conveys, implements and interprets policies and procedures. Makes recommendations regarding procedural matters or departmental improvements.
Performs basic nursing procedures such as phlebotomy, vital signs, and other tests specific to the study. Many administer treatments specific to the study.
Conducts in-service classes for nurses, pharmacists and other personnel for new investigational drugs and protocols.
Assist the Medical Director and Assistant Director as needed with all projects and duties
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
Minimum Education: Bachelor's degreeMinimum Experience: 2 yearsMinimum Field of Expertise: Registered Nurse, California Registered Nurse license, current CPR certification, clinical research experience and/or demonstrated experience specific to specialty of the study. Ability to communicate effectively and professionally with patients and their families, other medical staff and administrative personnel.
Internal Number: REQ20093249
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