IRB Coordinator

McKesson requires new employees to be fully vaccinated for COVID-19 as defined by the CDC, subject to applicable, verified accommodation requests.

McKesson Corporation is a Fortune 8 company and is one of the largest providers of healthcare supply chain management solutions, retail pharmacy, medical & pharmaceutical supplies, healthcare technology, community oncology and specialty care in the United States with revenues of $231 billion in 2020. The company was founded in 1833 by John McKesson and Charles Olcott in New York with a focus on importing and wholesaling pharmaceutical products. United by our ICARE shared principles, McKesson's 80,000 employees work together every day to make better care possible around the globe – one product, one partner, one patient at a time.

This position is responsible for reviewing all submissions to the Institutional Review Board (IRB) to ensure that IRB members have all the requisite information to review human subject research; enabling the IRB board members, including the IRB Chairpersons, to perform their review tasks by providing the necessary documents and education; acting as intercessory between the boards, researchers and other involved institutions; and performing other related duties as assigned.

Under minimal supervision, works to coordinate daily IRB activities to ensure protection of human subjects and compliance with laws and regulations related to human subject research conducted by the company and its affiliated network. Serves as resource related federal, state and institutional guidelines related to protection of human research subjects. Comprehensive understanding of US Oncology Research processes and operational goals. Adheres to the US Oncology Compliance Program, including the Code of Ethics and Business Standards.

• Maintains current knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations, guidance and standards.
• Reviews biomedical research studies for compliance with Federal regulations and Institutional policies and procedures.
• Interprets regulations and develop guidance documents for use by research department staff.
• Provides feedback, request additional information, resolve inconsistencies and clarify submission content (as necessary) to improve likelihood of obtaining committee approval to conduct or continue research at the time of review.
• Communicates with and guides investigators and research department staff on IRB requirements and procedures.
• Facilitates the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.
• Analyzes each submission by applying appropriate regulations and regulatory requirements to determine whether it meets criteria for IRB review.
• Assigns the regulatory risk determinations based on the research plan, study phase and methodology.
• Makes determinations for expedited review classification or defers the submission to the full board review if expedited classification is found not to be appropriate.
• Reviews submissions to evaluate accuracy and to determine appropriate review category per regulations and guidelines.
• Resolves moderately complex issues involving more advance research into ethical questions.
• Reports serious non-compliance issues to the IRB Manager and Research Quality Assurance Manager.
• Under minimal supervision, manages regular and special meetings of the IRB.
• Organizes meeting agenda to meet distribution deadline, disseminates meeting agendas and packets, coordinates and attends meetings.
• Prepares and distributes meeting materials to IRB members, obtaining any needed information and material.
• Records the decision making process of the IRB in official minutes, capturing and documenting summarization of any controverted issues and their resolution, clearness about the actions of the IRB and exactly what the IRB approved, clear specification of any modifications required to obtain approval, degree of risk, specific required determinations, members present at the meeting, members entering and leaving the meeting, alternate members attending and for whom they are substituting, votes on actions, names of IRB members who abstain, names of IRB members who absent themselves due to conflict of interest, attendance at the meeting for each action, basis for IRB requiring change in research, basis for disapproval of research, the rationale for significant or non-significant risk determinations, approval periods, and other regulatory requirements.
• Facilitates discussion to ensure appropriate quality of IRB review and documentation of discussion and determinations in minutes (as required by federal regulation).
• Generates follow up reports and other high level correspondence to communicate decisions of the IRB to investigators, sponsor and research central staff.
• Prepares and distributes decision letters and other appropriate documents on behalf of the IRB.
• Ensures that any post-meeting follow-up items are resolved in a timely manner.
• Maintains and monitors all clinical trial protocols, patient informed consent documents, etc. on the Clinical Trials Management System (CTMS) to ensure that these documents are current and accessible to investigators and site research staff.
• Distributes IRB approval documentation and post-meeting information to study sponsors, regulatory/safety staff and researchers (as appropriate).
• Prepares, maintains and updates IRB files per FDA guidelines.
• Makes files available for audit inspections. Ensures file is continuously updated and prepared for audits.
• Ensures all IRB files are prepared for off-site storage in accordance with FDA and other applicable regulatory guidelines.
• Makes files available for audit inspections. Assists the department in any Federal or Compliance audits.

Minimum Job Qualifications:

Education/Training – Bachelor’s degree in related field or High School Diploma (or equivalent) and minimum four years professional work experience, required.

Business Experience – 2 years experience in clinical research, regulatory compliance, human protections or IRB preferred. 1 year experience is required.

Specialized Knowledge/Skills – Ability to learn complex concepts (regulatory, ethical and scientific) and operate at a high level of interaction with researchers and board members. Must be skilled in interpersonal relationships and oral and written communication and be able to deal with high volumes and rigid deadlines. A demonstrated working knowledge of the federal regulations governing human subjects research is required. Sufficient professional experience, adequate education, and sound judgment to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures and regulations on human subject research issues. Ability to work independently and as part of a team inter-dependently with co-workers. Ability to effectively plan and organize projects impacting the work of others.

Working Conditions:

Environment – Work is performed in an office environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Requires significant interaction with clinical and corporate staff. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements (Lifting, standing, etc.) – The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is occasionally required to stand, walk and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. Requires vision and hearing corrected to normal ranges.

Must be authorized to work in the US. Sponsorship is not available for this position.

We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!

McKesson is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.

Current employees must apply through the internal career site.

Join us at McKesson!