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CLINICAL RESEARCH COORDINATOR, SENIOR - CLINICAL RESEARCH CANCER

Department:  Allied Health
Status:  Full Time
Shift:  1st

Reporting to the Director, Clinical Research, the Clinical Research Coordinators (CRC) are responsible for all aspects of clinical research activities and work in close cooperation with study physicians. The CRCs provide support, coordination, and leadership for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government-funded clinical research, and investigator-initiated clinical research.  The CRCs ensure a smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure.

 

The CRCs are involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders.  Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects.  The CRCs assist in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing, and close-out visits.  Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. 

 

 

Essential Functions

  • Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants.
  • Designs, implements and manages a system for organizing, planning workflow related to all research study activities.  Prepares and presents a summary of clinical trial activities if needed.
  • Be knowledgeable of study protocols to complete study activities correctly and completely.  Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice. Develops forms, checklists, and other tools to facilitate study completion and compliance.   
  • Assist the PI in the active recruitment and screening of potential research participants according to the protocol’s inclusion/exclusion criteria.  Schedule research participant’s visits in accordance with the study protocol.  Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol.
  • Draft or review template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines, and Hoag Policy language.
  • Discuss research study with potential research participants and answers any questions while coordinating the process of obtaining the research subjects informed consent prior to participation in the study. The CRC shall seek guidance from the Principal Investigator for any questions he/she cannot accurately answer for the research participant regarding the study or participant’s medical condition. 
  • Schedule or assist in scheduling follow-up visits for enrolled subjects
  • Document and report Unanticipated Problems, Adverse Events, and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
  • Complete the Case Report Forms for the study accurately and completely.  Abstract data from hospital records and physician charts to complete CRFs.
  • Work with ancillary staff areas (e.g. Operating Nursing Care, Cath Lab, Pharmacy, Pathology, Radiology, Laboratory, Medical Records) within the hospital affected by research activities.
  • Maintain accurate and complete records of the receipt, dispensing, and return of all investigational supplies, including study drug(s) or devices, and report any discrepancies to the PI and Sponsor.
  • Maintain the required regulatory and other documentation in the study documentation file.  Maintain records of research participants enrolled in the study.
  • Communicate with the study sponsor regarding study activities as necessary. Participates in required study visits such as Initiation Visit, Routine Monitoring Visits, Close-out visits, and audits. Reviews study records and meet with site visit teams/monitors, the FDA, or other inspectors as designated by the sponsor when required. Resolves queries generated from Sponsor or other monitoring/auditing reports.
  • Complete study Institutional Review Board submission application and ensures Investigator's review. Communicate with the designated IRB on study approvals/closures, and adverse event reporting
  • Work with the Clinical Research Office (CRO) administrative staff on all required aspects of study submission, continuing reviews, adverse event reporting, and study closure. Maintains current knowledge of Clinical Research Policies and Procedures. 
  • Work with Clinical Research Office administrative staff in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds.
  • Accommodate changes in workload within the department and demonstrates flexibility in accepting work assignments.  Performs assignments as directed by the Supervisor.

 

In addition to the above, the Senior Clinical Research Coordinator will be responsible for the following:

  • Work with Director of Clinical Research and Cancer Institute leadership, including USC, to operationalize and maintain operations for Phase 1 research.  Operations include equipment, staff training, space set up and compliance
  • Work with Cancer Center Leadership to manage expenditures for research within the Cancer Institute
  • Coordinate with USC, Cancer Center and other Hoag staff, as appropriate, for setting-up new research studies, including Phase I research, such as Clinical Outpatient Treatment Center (COTC) nursing staff, pharmacy, laboratory, research coordinators
  • Maintain all contracts for research with USC and work with Clinical Research Financial Specialist to execute invoices and payments as outlined in agreements
  • Work with USC staff including the Cancer Clinical Investigations Support Office (CISO) to activate new and maintain on-going research studies associated with USC including but not limited to IRB processes, USC systems (Café, iStar, etc.), pertinent informed consent language, etc.
  • Regularly communicates updates and status of cancer studies to Director of Clinical Research and appropriate medical staff, cancer research staff and other team members
  • Work with the Director of Clinical Research and Cancer Institute Leadership to develop and optimize processes between USC and Hoag.

 

 

Regulatory and Compliance Coordination Essential Functions

If assigned the Sr Clinical Research Coordinator or Lead CRC will be responsible for Regulatory and Compliance Issues including the following duties:

 

Investigator Coordination

  • Serves as primary WIRB contact & provides institutional authorization for new submissions.
  • Works closely with Investigators and Research Staff to prepare new study submissions to the regulatory authorities, IRB, and sponsors including initial submissions, amendments, safety reports, deviations, etc. to ensure timely, accurate submissions Maintains staff credentials including the CV, licenses, conflict of interest, etc.
  • Works closely with all sponsors to ensure all regulatory documents are reviewed, approved, and correct prior to a study opening to minimize delays to study initiation.
  • Participates in required teleconferences, on-site meetings, and off-site investigator meetings, as required.

Regulatory Submissions

  • Will ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
  • Reviews and completes CDAs for new studies assists with assigning study codes.
  • Obtains and completes all required documents for new submissions, amendment applications, and continuing review activities.

Research Compliance Analysis

  • Documents and tracks research training of investigators and research staff.
  • Reviews informed consent for institutional language and work with legal to ensure CTA language is consistent with consent.
  • Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops, and implements systems to decrease the delay in the approval process.
  • Participate in internal and external monitoring, audits, and/or regulatory authority inspections while working.
  • Reviews and evaluates communications to ensure that communications convey all necessary detail and adhere to applicable regulatory standards including those set by the regulatory agencies.

Study Maintenance

  • Maintain pertinent clinical trial regulations to ensure submission requirements are current, up-to-date, and are entered into regulatory submission database and file systems.  Ensure that information on such regulations and requirements, especially those that are new or modified, are distributed to the study team and other appropriate personnel.
  • Registers & maintains clinical trials on clinicaltrials.gov website for applicable studies & works with sponsors to include Hoag.
  • Maintains and updates the study management portion of the clinical trial management system.
  • Maintains share drive, master study sheet, departmental Wave website, and clinical research files. Tracks SAEs & inputs into a clinical research database on a needed basis.
  • Will produce and maintain regulatory binders prior to the study starting with all required documents and additional sections for future documents and dedicated electronic study folder.
  • Maintains a working knowledge of current protocols and internal SOPs; Reviews protocols and reports to support regulatory submissions.
  • Assists in the development and maintenance of SOPs including work instructions, forms, and templates. 
  • Communicates regularly with Research Staff to review data accuracy, clinical data quality, and overall study progress.
  • Assists in the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for the maintenance of INDs or IDEs.

Staff Support

  • Works with external researchers to complete the External Visitors Checklist to meet badge requirements for access to institutions.

 

Education, Training, and Experience:

 

Required:

  • Must have an AA degree or current ACRP or SoCRA Certification
  • Minimum 1 (one) year of Clinical Research Coordinator experience.
  • Patient coordination experience in complex clinical trial settings required (does not include Regulatory position).
  • Medical terminology required. 
  • Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.  Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
  • Knowledge in one assigned clinical area. 

 

Sr. Clinical Research Coordinator

In addition to the above:

 

Required:

  • Bachelor’s Degree or current ACRP or SoCRA Certification
  • Minimum 2 (two) years of Clinical Research Coordinator experience.

 

Preferred:

  • In-depth Regulatory knowledge

 

 

Skills or Other Qualifications

 

Required:

  • A high degree of attention to detail and ability to follow instructions.  
  • Good writing, oral, and presentation communication skills. 
  • Works well independently. 
  • Maintains subject and appropriate study related material confidentiality. 
  • Effective interpersonal skills required to interface between departments, other coordinators, investigators, medical records, and Institutional Review Committee. 
  • Computer knowledge in Microsoft Windows applications including Word, Outlook, and Excel, and familiarity with electronic data capture systems preferred. 
  • Ability to be proficient at additional specialized software and systems required. 

 

Preferred:

  • N/A

 

Position Reports to: Director of Clinical Research

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