This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office.
SUMMARY
Under guidance of the Director, Quality Assurance, and in collaboration with Clinical Trials Center departments, the Manager, Quality Control & Clinical Documentation is responsible for coordination of activities with regulated departments within the Clinical Trials Center ("CTC") to facilitate their adherence to Standard Operating Procedures ("SOPs"), maintain compliance with the Foundation’s Quality Training program, facilitate internal quality audits as well as external regulatory or Sponsor audits, and support collection and quality review of clinical study documentation, as required.
The Manager, Quality Control & Clinical Documentation will maintain general CTC training records and study-specific training records and assist in preparation for client/sponsor audits of the CTC.
The Manager, Quality Control & Clinical Documentation will be responsible for query resolutions, supporting Core Lab Variability Testing procedures, and training within the various Core Laboratories, as applicable.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Additional duties as assigned, working in close collaboration with the Director of Quality Assurance and Clinical Trials Center departments and leadership.
- Responsible for oversight, management, and updating of all CTC procedures and related documents within the Quality Management System.
- Acts as liaison on Regulatory and client/sponsor audits, while supporting internal audits of the Clinical Trials Center functional areas.
- Acts as liaison on development and implementation of CAPAs required in response to audit findings, observations, or Sponsor-requested/initiated non-conformances.
- Provides oversight and management of pre-qualification vendor and supplier audits.
- Works with Information Technology and CTC Functional Areas on the installation, updating, validation, and periodic testing of CTC software.
- Ensures CTC training files (both general and study-specific) are complete and up to date and are properly maintained within internal network folders or a related Trial Master File, as applicable.
- Identifies and resolves internal Foundation quality issues within the Foundation’s Quality Management System (e.g., identifies and helps resolve problems and/or issues with processes across departments/functional areas, following through to Effectiveness Checks, as applicable.
- Assists with computer system validation ("CSV") initiatives and the QA review and documentation of such validation and implementation efforts to meet requirements of the FDA and other regulatory authorities.
- Conducts periodic internal quality assurance audits within the CTC to include a review of clinical trial data, applicable databases, regulatory documentation, and trial master files.
- Reviews study documentation for compliance with Foundation SOPs, formatting, data security, and regulatory requirements.
- Ensures that timely training to SOPs, regulatory requirements, and quality initiatives is conducted, and that quality policy training files are maintained and up to date.
- Manages, organizes, and coordinates updates of relevant staff Curricula Vitae and related Job Descriptions, working with both Foundation Information Technology and Human Resources as necessary.
- Actively participates in client/Sponsor audits, periodic internal audits, and regulatory inspections of the Foundation.
- Leads the CTC staff in the resolution of quality systems issues, updates to clinical or administrative databases, and periodic testing of such clinical systems.
- Conducts quality reviews of computer system validation reports in accordance with 21 CFR Part 11 and Foundation process and procedures.
- Performs other duties as assigned by the Head of Quality Assurance.
QUALIFICATIONS
- Bachelor's Degree in a scientific or health-related field, plus 3-5 years of experience or familiarity with Phase I-IV clinical trials and knowledge of GxP-regulated research required.
- Related medical training (Master’s Degree, medical certification or credential, etc.) preferred.
- At least 2-3 years of experience or familiarity with QA/GxP auditing across a broad range of audit activities (e.g., clinical sites, Sponsors, vendors), and internal systems or analysis platforms preferred.
- Working knowledge of US and international quality regulations, guidelines, and standards governing the conduct of clinical trials.
- Working knowledge of HIPAA, HITECH, European Union’s GDPR, 21 CFR Part 11, and FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application.
- Successful candidates will also possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits.
- Training in GxP or GCP/ICH regulations.
- Proficient with Microsoft Outlook, Word, Excel, and Access. General computer proficiency a must. Familiarity with clinical databases or analysis platforms preferred.
- Must possess excellent communication and writing skills, patience, professionalism, and ability to effectively interact with staff, management, and external parties alike.
- Ability to verbally communicate effectively with data management, core laboratories, department clinical research and other team members.
- Ability to multi-task and interface with users who are working under deadlines. Ability to set priorities and excellent organizational planning, project management, system lifecycle management and time management skills.
- Ability to accurately project time to complete tasks and communicate this information effectively to project teams.
- Must have the flexibility and willingness to occasionally work evenings and weekends in order to meet research study and internal Quality Assurance deadlines.
- Ability to analyze information and solve problems relating to workflow, scoped analyses of various core laboratories, statistical/data errors, data queries, budgets, contracts and performance assessments or trainings.
BENEFITS
- Choice of health plans include medical, Dental, and vision coverage
- Company-paid short-term and long-term disability and life insurance
- Health and dependent care flexible spending accounts
- Pre-tax travel expenses through TransitChek program
- 401(k) plan
- Generous paid time off (PTO)
- Ten paid holidays each year
COMPENSATION
The hiring range for this position is $75,000 - $90,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience.
CONTACT INFORMATION
To be considered for this opportunity, please submit your resume.
Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day www.crf.org
CRF is an equal opportunity employer.
Job Type: Full-time
Pay: $75,000.00 - $90,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Clinical trials: 3 years (Required)
- HIPAA: 1 year (Preferred)
Ability to Commute:
- New York, NY 10019 (Required)
Ability to Relocate:
- New York, NY 10019: Relocate before starting work (Required)
Work Location: Hybrid remote in New York, NY 10019