Clinical Research Quality Assurance Program Manager/Auditor

4 days left

Washington, District of Columbia-Washington
Aug 19, 2020
Sep 23, 2020
Full Time
Reporting to the Vice President of Research Administration, the Clinical Research QA Program Manager/Auditor manages the Clinical Research QA Program, with a focus on performing comprehensive audits and monitoring of Investigator-initiated clinical trials conducted under a Food and Drug Administration (FDA) IND/IDE, and other high-risk protocols as necessary. The individual is responsible for planning, coordination, control, and continuous improvement of processes and methods to ensure conformance to internal and external quality standards at Children's National and directs quality assurance and compliance functions. The individual will perform extensive audits and monitoring visits to determine compliance with IRB approved protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP) and applicable regulatory requirements. Together with Senior Management the individual implements a quality assurance/regulatory strategy for the institution to ensure compliance with all applicable regulatory requirements and makes recommendations to Senior Management and Leadership regarding the specific activities and resources required to support this strategy. The individual is responsible for developing and implement a detailed audit plan and SOPs, managing the internal auditing functions and developing training programs, consistent with organizational needs and in accordance with current international GCP/GMP requirements. The individual serves as an internal resource to principal investigators and provides guidance with IND/IDE submissions, and partners with other on developing a comprehensive clinical research regulatory and support infrastructure. The position serves on committees and represents the program with professional organizations.


Minimum Education
Bachelor's Degree

Specific Requirements and Preferences
Completion of an accredited Nursing (RN), Physician Assistant, or Bachelor's Degree in related healthcare, preferred and/or extensive clinical research.

SoCRA Certified Clinical Research Professional (CCRP) or ACRP Certified Clinical Research Coordinator (CCRC) required.
ACRP Certified Clinical Research Associate (CCRA)-preferred.

Minimum Work Experience
5 years

Specific Requirements and Preferences
Requires a minimum of 5-6 years of experience in the pharmaceutical, medical device, biotechnology or contract research industry including a minimum of 4 years in quality assurance/regulatory affairs, auditing, clinical research, monitoring, data management or other relevant area, including 3-4 years of applicable GCP and GMP compliance and auditing. Knowledge of GCP and ICH regulations and auditing techniques. Excellent communication and organizational skills and superb attention to detail.
• Experience with MS Office products and database applications required.
• Excellent inter-personal skills and customer service focus is required.
• Experience in clinical research management and oversight, including project management in a dynamic research setting.
• Experience in developing and implementing training/education.
• Demonstrated ability to manage multiple projects and staff under varying time constraints.
• Strong writing skills.

Required Skills/Knowledge
Management experience,Strong organizational, negotiation, interpersonal, verbal and written communication skills, and attention to detail.
Experience working with pharmaceutical and FDA agency representatives.
Demonstrated communication, leadership, and team building skills; Evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing and directing the activities of others. Advanced Project management skills.

Functional Accountabilities

Responsible Conduct of Research
1. Ensure compliance with standards for the responsible conduct of research, research ethics and integrity, safety and compliance, including data security, privacy, confidentiality and human subjects protection.
2. Plan, conduct, and manage audits within the federal, local and institutional regulations, policies and procedure, guidelines and standards
3. Assist research teams with the timely filing of regulatory documents and monitor compliance with relevant laws and regulations.
4. Responsible for appropriate use of research funds and resources.
5. Ensure compliance with all annual training requirements.
6. Maintain professional growth and development and enhance quality improvement initiatives and regulatory compliance through seminars, workshops, and professional affiliations to keep abreast of the latest trends in field of expertise.
7. Partner with Compliance and Research Program staff to foster a culture of compliance and the development and implementation of action plans in preparation or response to external or internal audits

QA Audits
1. Schedule, conduct and document compliance auditing activities associated with clinical research studies that include but are not limited to the review of all research-related activities, and document to assess and evaluate the compliance of those activities to internal policies, standards operating procedures (SOP's), and relevant regulatory requirements.
2. Follow up as appropriate to obtain audit response. Review responses to audit findings for appropriateness and completeness.
3. Ensure that the required number of audits are conducted each quarter, directing staff and supporting team members with audits as needed.
4. Assist research teams to plan and prepare for external audits. Provide a draft audit agenda to internal participants. Assist and facilitate external audits.
5. Conduct audit debriefs with project teams and/QA Program leadership as required

QA Program Management
1. Manages the daily operations of the Clinical Research QA Audit Program
2. Maintain institutional database of all IND/IDE submissions and external FDA and sponsor audits and provide reports as requested
3. Coordinate the QA Program Executive Committee and IND/IDE Scientific Review and Feasibility Committee activities
4. Collaborate with Principal Investigators and Research Teams on audit findings, corrective action and preventive plans
5. Work with QA Leadership to provide feedback, deficiencies and common trends identified in audits to ensure timely and effective change control to improve overall quality
6. Facilitate regulatory inspection
7. Develop quality and risk assessment tools and checklists
8. Analyze and propose best practices for implementing and conducting audits and investigations
9. Participate in inspection readiness plans and activities
1. Continuously validate and verify information needed for decision making or documentation
1. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance
1. Ensures with QA leadership that the implemented research audit program is appropriate in scope, that identified issues are corrected and educational programs are available for investigators and research staff.

Education Program & P&P Development
1. Stay current with regulatory, quality, and industry trends related to GCP
2. Draft, revise, and update Quality Assurance SOP's, P&P and other QA documents
3. Serve as a mentor to other QA auditors and coordinators and provide feedback to them
4. Develop quality and risk assessment tools and checklists
5. Perform cause analysis to identify source of problems or non-conformances.
6. Oversee department training and development including identification of training needs
7. Develop training programs and partner in strategic initiatives
8. Maintains subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.

Human Research Managerment
1. Establish, and maintain an organizational structure and staffing to effectively accomplish the organization's goals and objectives; manage recruitment, training, supervision, and evaluation of staff.
2. Directly supervise Clinical Research Audit Staff. The management of this staff includes: direct day-to-day supervision, training, mentorship and evaluation of the staff, and providing coverage when needed.
3. Define, set and utilize appropriate performance and quality measures staff
4. Sees oneself as a leader of others, demonstrate commitment to continuing professional education, holds the team members accountable individually and as a group for results.
5. Establish, build and sustain professional contacts for the purpose of building networks of people with similar goals that support similar interests.

Organizational Accountabilities

Organizational Commitment/Identification

1. Anticipate and responds to customer needs; follows up until needs are met


1. Demonstrate collaborative and respectful behavior
2. Partner with all team members to achieve goals
3. Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

1. Contribute to a positive work environment
2. Demonstrate flexibility and willingness to change
3. Identify opportunities to improve clinical and administrative processes
4. Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

1. Use resources efficiently
2. Search for less costly ways of doing things


1. Speak up when team members appear to exhibit unsafe behavior or performance
2. Continuously validate and verify information needed for decision making or documentation
3. Stop in the face of uncertainty and takes time to resolve the situation
4. Demonstrate accurate, clear and timely verbal and written communication
5. Actively promote safety for patients, families, visitors and co-workers
6. Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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