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Clinical Research Coordinator - 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.
  • Perform other duties as assigned.

 

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. 

 

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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