Senior Clinical Research Regulatory Specialist

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Date: May 31, 2019

Location: Newport Beach, CA, US

Company: Hoag Memorial Hospital Presbyterian

Job Description:

Reporting to the Director, Clinical Research, the Clinical Research Coordinators (CRC) are responsible for all aspects of clinical research activities and works 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 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 a 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

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 report, 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 complete 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 consents for institutional language and works 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 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-todate and are entered into regulatory submission database and file systems. Ensure that information of 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 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 clinical research database on as 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 working knowledge of current protocols and internal SOPs; Reviews protocols and reports to support regulatory submissions. 4

 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 maintenance of INDs or IDEs.


Staff Support

 Works with external researchers to complete External Visitors Checklist to meet badge requirements for access to institution.



Education, Training and Experience

Clinical Research Coordinator


 Must have AA degree or current ACRP or SoCRA Certification

 Minimum 1 (one) year of Clinical Research Coordinator experience.

 Patient coordination experience in complex 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. Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.


Sr Clinical Research Coordinator In addition to the above:


 Bachelor’s Degree

 Knowledge in clinical area designated


Skills or Other Qualifications


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 Clinical Research Coordinator


Holds current ACRP or SoCRA certificate (or complete within two years of hire)



Nursing Degree in LVN or LPN


Sr.Clinical Research Coordinator


 Holds current ACRP or SoCRA certificate (or complete within two years of hire)



Nearest Major Market: Orange County
Nearest Secondary Market: Los Angeles

Job Segment: Clinic, Regulatory Affairs, Medical, Clinical Research, Healthcare, Legal, Research

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