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Clinical Research Coordinator - Clinical Research Cancer

Department:  Support Services
Status:  Full Time
Shift:  1st

The Clinical Research Coordinator (CRC) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The CRC provides support, coordination and leadership for FDA regulated and non-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 CRC ensures the smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. This position reports to the Program Manager of Clinical Research.

 

The CRC is involved in all aspects of research studies from protocol review, preparation, review, 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 patient follow-up, and maintenance of regulatory binders. Discusses research study with potential study patients and answers any questions while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled patients. 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 their scope of practice, billing compliance, Good Clinical Practices, protection of human subjects training, and FDA regulatory guidelines regarding clinical research. Reports to the local Research Program Manager and works as a team member to support the growth and vision of the research program.

 

If the CRC is designated responsibilities for Regulatory and Compliance Coordination, the duties are detailed below separately

 

Job Specific Essential Functions:

 

  • Assist the Investigators 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.
  • Supports 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 with one's scope of practice. 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 Investigators in the active recruitment and screening of potential research participants according to the protocol’s inclusion/exclusion criteria. Schedule a research participant’s visits in accordance with the study protocol. Assist the Investigators in the training of other site personnel and other medical staff in understanding and implementing the protocol.
  • Reviews template Informed Consent Forms per FDA, ICH, GCP guidelines and St. Joseph Health Policy language.
  • Discusses research study with potential research participants and answers any questions while coordinating the process of obtaining informed consent prior to participation in the study. The CRC shall seek guidance from the 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 patients
  • Documents and reports Unanticipated Problems, Adverse Events, and Serious Adverse Events according to local policy, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator for approval prior to reporting, Sponsor, 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 as appropriate 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, and Close-out visits.
  • 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 reports. Work with the 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.
  • Accommodates 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.

 

Regulatory and Compliance Coordination Essential Functions:

If the CRC is requested to be responsible for Regulatory and Compliance Issues, he/she will have the following duties:

  • Study Maintenance: maintains clinical research data worksheets, shared drive and clinical research files.
  • Investigator Coordination: Reviews and maintains records of Investigator qualification for research. Receives and performs quality assurance review for completeness of all investigators reported Serious Adverse Events.
  • Routes appropriate SAE reports to the IRB and Quality Management Office within regulatory requirements.
  • Staff Support: Assists with meeting coordination within the program.
  • Functions within a team framework. Reviews IRB documents for completeness, consistency, and accuracy.
  • Supports immediate and long term goals of the Research Program.

 

Education, Training, and Experience:

 

Required:

  • Minimum of 5 (five) years of Clinical Research Coordinator experience if no Oncology Research experience. 
  • High School Diploma or GED.
  • Patient coordination experience in a clinical trial setting required (does not include Regulatory position).
  • Medical terminology required.
  • Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
  • Holds current ACRP or SoCRA certificate (or complete within two years of hire)

 

Preferred:

  • Nursing Degree in LVN
  • Bachelor’s Degree
  • Familiar with medical areas of oncology, neurosciences, cardiovascular medicine, orthopedic, infectious disease, or endocrinology research.

 

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.

 

License and Certifications:

 

Required:

  • Holds current ACRP or SoCRA certificate (or complete within two years of hire)
  • A valid current Certified Phlebotomy Technician I by the State of California (or completed within one year of hire),

 

Preferred:

  • Nursing Degree in LVN or LPN
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