We are seeking a Clinical Research Coordinator 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 support to the DAIT Quality Assurance (QA) Manager for clinical quality assurance activities.
Provide Quality Assurance document management/control support in electronic clinical quality assurance systems (i.e., Master Control).
Participate in quality assurance activities related to the close out of DAIT projects (such as file audits, tracking, reconciliation and transfer of clinical study files (onsite and offsite).
Transmit safety information communications from study drug manufacturers providing study drug for DAIT sponsored clinical trials to DAIT Regulatory Management Center (RMC).
Participate in the development and implementation of written project work instructions and standard operating procedures to harmonize operational processes internally at DAIT and in collaboration with the Regulatory Management Center; identify new processes, build teams, development and negotiation of ideas from concept to written and approved process.
Perform quality assurance review of Office of Regulatory Affairs documents to include (but not limited to) contract agreements, audit reports, and other related clinical documents.
Perform reconciliation of receipt/distribution of safety information at request of ORA staff and/or study drug manufacturers.
Respond to queries regarding safety information received/distributed.
Lead DAIT ORA weekly staff meetings (schedule, generate agenda, update action items).
Serve as the primary QA point person for DAIT ORA archive files stored at Iron Mountain for long term storage of regulatory documents.
Manage distribution and tracking of all official Health Authority (HA) correspondence (US and Other) to include HA submissions, reporting.
Assume responsibility for the ORA file room (HA communication) by taking charge of tasks related to organization, space allocation and archiving with emphasis on maximal utilization of space.
Manage all incoming documents (HA Letter, faxes, etc.) to include scanning, distribution to the RMC and filing.
Qualifications
Master's degree in a related discipline. Three (3) years of specialized experience plus a Bachelor's degree is equivalent to a Master's degree.
Minimum of one (1) year of related management experience is required.
Computer experience with Microsoft Office Suite, Master Control, or similar document system is preferred.
Excellent skills in oral and written communications, computer competency, document control and attention to detail are required.
Demonstrate superior knowledge of research protocols and clinical, scientific and/or medical terminology.
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.
CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.
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.
