Job Details
Overview
We are seeking a Project Manager to support the National Institutes of Health s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.
Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.
Responsibilities
- Provide quality management support for Division clinical research activities.
- Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities.
- Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
- Support the development and implementation of the Division s electronic Quality Management System (eQMS).
- Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
- Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
- Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
- Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies.
- Review, track and/or trend routine quality data.
- Report adverse trends to management with proposed remediation plan.
- Coordinate the development of various QA related metric reports.
- Work with other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID.
- Based on understanding of Division operations, look for ways to standardize processes to improve quality and/or facilitate efficiency.
Qualifications
- Bachelor s degree in a related discipline.
- Minimum of five (5) years of experience in clinical research or a related field.
- Experience in establishing and managing quality management systems for clinical research for IND sponsors (e.g. in pharmaceutical companies, biotechnology companies, or government sponsors).
- Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes.
- Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
- Knowledge of electronic clinical quality management systems such as Master Control is preferred.
- Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
- Experience conducting or overseeing audits is preferred.
- Experience working at a clinical research site is preferred.
- Experience in the NIH or other government agency is preferred.
- Excellent communication skills both verbally and written; and across functions internally and externally.
- Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
- Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in order to effectively solve problems.
- Excellent multi-tasking, analytical, organizational and teamwork skills.
- Ability to troubleshoot, identify root cause and systematically resolve problems.
- Ability to produce high-quality work on complex problems with cross-functional involvement.
- Proficient in Window based software to include Excel, Word.
CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com. CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.
Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.
Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.