Clinical Operations Manager

CAMRIS • Bethesda, MD

15h • Onsite

About The Position

We are seeking a Clinical Operations 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 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 two to three (2 - 3) years of Project Management, Scientific Program Analysis, or Scientific Review experience. Desired Master’s degree in Project Management or PMI certificate with 0 – 1 years of experience.
• Minimum of 2-3 years of related experience in clinical administrative operations, clinical protocol review, and international clinical coordination.
• Minimum of 2-3 years of related experience in administrative operations as it relates to tracking supplies, requesting the purchase of specific supplies, data management, and protocol management.
• Background in biology, chemistry, and/or biophysics.
• Excellent documentation and communication skills.
• Basic computer skills including experience with Microsoft Word, Excel, Teams, SharePoint, and Project.
• Ability to lift or carry less than 25 pounds, lift or carry 25 – 50 pounds, push or pull less than 25 pounds, push or pull 25 – 45 pounds, reach above shoulder level, and use both hands.
• Will be required to stand or walk more than 25 of 30 min., and bend repeatedly.
• Must have depth perception, have correctable near vision, ability to distinguish basic colors, and perform repetitive activities.
• Ability to work alone and closely with others, work protracted or irregular hours, work on slippery or uneven working surfaces, and work with hands in water.
• Will be required to be in contact with human blood or other body fluids.
• Must be able to wear personal protective equipment (PPE), including gloves, safety glasses, and lab coat.

Nice To Haves

• Desired Master’s degree in Project Management or PMI certificate with 0 – 1 years of experience.

Responsibilities

• Provides technical experience needed to manage the operations and functions within the clinic.
• Plans, coordinates and manages various programs and work projects.
• Coordinates revisions to current clinical program activities.
• Coordinates special clinical projects.
• Coordinates the activities of various clinical committees by providing logistical and technical support.
• Acts as liaison with staff and other government and non-government offices.
• Ensures compliance with required program, administrative and management deadlines.
• Collects, enters, and updates data into tracking database.
• Assists with budget tracking and protocol management.
• Performs various clinical literature searches and receives, reviews, and prepares clinical/technical reports.
• Requests and initiates the purchase of materials, supplies and equipment.
• Arranges/coordinates scientific meetings, seminars, and conferences and provides appropriate background materials.
• Assists with coordination of clinical activities both in the United States and internationally to track timelines for all clinical activities including regulatory submissions, regulatory responses, and other clinical administrative functions.
• Responsible for maintaining all patient records, reviews records for accuracy, stores records according to current federal regulations, ensures confidential information is retained in accordance with data protection policies.
• Leads recruitment efforts to recruit volunteers to participate in clinical studies by developing phone scripts, conversing with potential volunteers, and interfacing with participants.
• Develops quality management plans for domestic clinical studies.
• Interacts with Institutional Review Board (IRB), PI’s, clinical research staff, and reports adverse events to IRB, Sponsors, and other relevant groups.
• Reviews electronic and paper Case Report Forms (CRF) for completeness, accuracy, consistency, and compliance with regulations and policies.
• Assists other members of the lab and FTL with keeping databases updated, such as REDcap, iDataFax, CRIMSON, CRIS, and Freezerworks.
• Assists with reviewing field budgets for international clinical studies at field sites.
• Contributes to the organization and publishing of scientific publications and manuscripts.
• Creates timelines, schedules, calendar invites, and organizes attendee lists for several scientific team meetings to discuss a variety of scientific programmatic deadlines and planning timelines.
• 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