Regulatory Coordinator

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This position is responsible for organizing, planning and controlling workflow of all clinical research regulatory activities. The Regulatory Coordinator is required to have an in-depth knowledge of all Codes of Federal Regulations and Good Clinical Practice Regulations pertaining to clinical research activities. As the primary resource for this aspect of clinical trials, the coordinator will act as liaison between the investigators, the institutional review board (IRB), and the research bases and/or study sponsors.

The Regulatory Coordinator will be required to become familiar with all research base audit manuals, policies and procedures.

Include the following. Other duties may be assigned.

• Maintain cooperative relationship with co-workers, component hospital departmental staff, investigator medical office staff, affiliate member staff, research base contacts, and clinical research participants.
• Answer telephone, screen calls, take messages, and provide information to appropriate staff.
• Communicate on a regular basis with investigators and office nurses regarding the availability of clinical studies.
• Communicate IRB preparation and submission.
• Communicate any Regulatory/Audit discrepancies and/or concerns to the Administrator and the Principal Investigator.

• Review new protocols for applicability.
• Complete application forms and HIPAA forms for new studies.
• Review amendments/ local consents for accuracy in changes.
• Complete continuing review forms and amendment cover letters for IRB.
• Present amended studies at IRB meetings.
• Assist PI in presenting new studies at IRB meetings.
• Orient new staff members to regulatory requirements policies.
• Serve as a resource for all offices regarding federal regulations.
• Track internal protocol deviation reports and unanticipated problems reports & ensure appropriate entities receive the reports.
• Distribute, track, and submit IRB FCOI forms and Federal Investigator forms for appropriate staff and physicians.
• Serve as the HIPAA privacy compliance officer, orient staff on a regular basis.
• Monitor the need for reconsenting patients; provide the appropriate consents to the research staff.
• Complete & submit to IRB requests for reconsent waivers.

• In administrator’s absence, carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Certified Clinical Research Professional, Registered Nurse, or B.S. in Health-Related Field. Equivalent related work experience may be substituted for educational experience. Oncology and/or clinical research experience preferred. Computer experience in Database software, Internet software and Word Processing software preferred.

• Behavioral
  
  Skills:
  
  Follows policies and procedures;
  Supports organization’s goals and values;
  Prioritizes and plans work activities;
  Uses time efficiently;
  Maintains research patient/participant confidentiality.
• Technical
  
  Skills:
  
  Demonstrates accuracy and thoroughness;
  Looks for ways to improve and promote quality;
  Applies feedback to improve performance;
  Monitors own work to ensure quality and completes work in timely manner;
  Identifies and resolves problems in a timely manner.
• Project Management: Develops project plans;
  Coordinates projects;
  Communicates changes and progress.
• Oral Communication: Speaks clearly and persuasively in positive or negative situations;
  Listens and gets clarification;
  Responds well to questions;
  Demonstrates group presentation skills;
  Participates in meetings.
• Written Communication: Writes clearly and informatively;
  Able to read and interpret written information. Able to write reports, business correspondence, policies and procedures.
• Professionalism: Approaches others in a tactful manner;
  Reacts well under pressure;
  Treats others with respect and consideration regardless of their status or position;
  Accepts responsibility for own actions;
  Follows through on commitments.
• Safety and Security: Observes safety and security procedures;
  Reports potentially unsafe conditions;
  Uses equipment and materials properly.
• Adaptability: Adapts to changes in the work environment;
  Manages competing demands;
  Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality: Is consistently at work and on time’;
  Ensures work responsibilities are covered when absent;
  Arrives at meetings and appointments on time.
• Dependability: Follows instructions, responds to management direction;
  Takes responsibility for own actions;
  Keeps commitments;
  Completes tasks on time or notifies appropriate person with an alternate plan.