Coordinator, Regulatory/ Compliance-Center for Health Research

Description : Job Summary :

To execute and coordinate all clinical trial regulatory activities and requirements for the Clinical Research Support Services Department and to ensure compliance with all government regulations utilizing a formal quality management program.

Essential Responsibilities :

Coordinate accurate quality data collection and protocol interpretation as it relates to regulatory affairs. Prepare regulatory documents for successful submissions to KPNWs Institutional Review Board.

These include review requests for new protocols, amended protocols, investigative drug brochures, IND safety reports, serious adverse event reporting, annual reports, and changes to informed consents and protocol deviations / violations.

Collaborates with study sponsors to ensure understanding of protocol, informed consent, and other regulatory requirements.

Collaborate with study team members to clarify scientific and clinical issues. Practice according to professional, legal, and ethical standards.

Develop and implement systems and reports to support department and regulatory needs. Assist the department in evaluating systems and processes to promote effective resource utilization.

Coordinate specific regulatory assignments to support the goals of the department, the oncology clinic, and the studies.

Act as a resource to staff for managing regulatory issues. Prepare and submit regulatory documents to sponsors as appropriate.

Ensure study administrative regulatory files are accurate and up to date. Take a leadership role in developing a quality management process within the department that includes quality control, quality assurance, and quality improvement.

Communicate study-related issues, such as protocol violations and patient safety to appropriate persons. Coordinate and organize all regulatory documents and maintain the database with all pertinent regulatory information.

Apply thorough knowledge of GCP (Good Clinical Practices), Institutional Review Board, and FDA (Federal Drug Administration) rules and regulations that apply to human subjects research.

Anticipate fluctuations in work flow and make appropriate adjustments to meet standards and deadlines. Prepare and assist with all regulatory audits.

Provide ongoing review and updates of department policies and procedures to ensure compliance with CHR / KP standards as well as government regulations.

Establish, plan, and coordinate channels of communication between research staff, PIs and KPNW Research Subject Protection Office (RSPO) to solve problems effectively.

Establish positive working relationships with Principal Investigators, RSPO staff and other members of the study team to ensure timely, accurate verbal and written communication of study related regulatory activities.

Provide timely, accurate communication to appropriate study team members of changes in regulatory interpretations and / or reporting requirements as required by the RSPO.

Collaborate with the RSPO to ensure compliance with all institutional and regulatory requirements. Generate invoices to sponsors for IRB / regulatory related charges.

Demonstrate a thorough knowledge of communication skills by contributing productively to problem solving and conflict resolution.

Take a leadership role regarding regulatory related activities working with a multi- disciplinary team. Act as a role model, developing and participating in collaborative relationships with other staff members.

Provide regulatory interpretation and clarification to team members. Integrate the department purpose / mission / vision / values into practice.

Basic Qualifications : Experience

Minimum one (1) year in a clinical trial setting.

Education

• Bachelors of science degree OR four (4) years of experience in a directly related field.
• High School Diploma or General Education Development (GED) required.

License, Certification, Registration

N / A

Additional Requirements :

• Strong computer skills preferably Microsoft Word and Excel.
• Proficient in accessing and downloading information from web sites.
• Excellent written and verbal communication skills; meticulous organizational and attention-to-detail skills.
• Ability to work well with others in various departments under pressure, and meet time deadlines; flexible, able to multi-task and prioritize work.
• Working knowledge of medical terminology.

Preferred Qualifications :

• Minimum two (2) years in clinical trial setting.
• Minimum two (2) years of research experience in clinical research setting and experience abstracting data.
• Thorough knowledge of MS Office software and database management.
• Knowledge of FDA regulations as they pertain to the protection of human subjects.
• Thorough understanding of medical terminology.
• Masters degree in related field.
30+ days ago