Scientific Reviewer

CAMRIS • Bethesda, MD

4d • Onsite

About The Position

We are seeking a Scientific Reviewer 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 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Requirements

• Bachelor's degree in a science related field with at least five (5) years of Quality Assurance, Project Management or Scientific Review experience.
• Minimum of five (5) years of related experience in MasterControl, Jira or other regulatory software.
• Minimum of five (5) years of related experience or understanding of Good Manufacturing Practice (GMP) and document review of CMC documentation for IND submissions.
• Experience and organization with record keeping for Laboratory notebooks, protocols, and SOPs.
• Excellent documentation and communication skills.
• Basic computer skills including experience with Microsoft Word, Excel, SharePoint, and MasterControl.

Nice To Haves

• Demonstrated understanding of malaria is highly desirable.

Responsibilities

• Performs writing and review of a variety of research documents including but not limited to SOP’s, Batch Production Records, proposals, reviews, letters of recommendation, and other programmatic documents in preparation.
• Maintain and records notes at assigned meetings to collect information to develop Gantt charts, timelines, and other deliverables for the program.
• Responsible for QA and reviewing documents for accuracy before submission to regulators, upper management, and international collaborators working with program on various projects.
• Provide project management support in all areas of the program through clear communication on agenda items to provide high level objectives and specific action items in notes.
• Assist with collaborations in various ways in support of programs mission activities.
• Provides support for program through functional operations, explaining programmatic processes and procedures, and maintaining a high level of quality assurance for program.
• Provide Quality Assurance (QA) for program for all regulatory documents, including but not limited to administrator on the MasterControl document control program.
• Maintain and organize and issuance of all Laboratory notebooks for the program, collection of completed notebooks, review, and archiving for permanent record.
• Review and comment on documents submitted for review including but not limited to protocols, Standard Operating Procedures (SOP), Master Protocols, Laboratory Protocols, Animal Protocols, Batch Production Records. Digitizing documents for uploading into MasterControl.
• Performing QA review, execution and closeout on laboratory work related records for the program. Digitizing and archiving completed protocols, SOPs, production records and other paper documents other than laboratory notebooks. Obtaining signatures as needed on reviewed documents. Archiving all records into MasterControl document preservation software.
• Performs other duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees