The Infectious Disease Clinical Research Consortium (IDCRC) is an NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases.
FHI 360 has partnered with Emory University to participate in leadership activities and serve as the Protocol Management Center for IDCRC driven research, leading study development and implementation funded by the Division of Microbiology and Infectious Diseases of the U.S. National Institute of Allergy and Infectious Diseases.
The Clinical Research Manager (CRM) I supports the clinical operations teams in the implementation of clinical trials. The CRM I assists in the development, implementation and management of clinical research studies, from protocol development and study start-up, to study completion and publications. Primary duties include assisting in managing cross-functional study teams, tracking site activities and progress, facilitating communications, quality control of study documents, managing study files, and coordinating study reporting, among other activities. All activities performed are under supervision by senior staff.
Responsibilities:
The CRM I assists in the management of one or more clinical studies, partnered with a clinical trials assistant, through the following activities, all under appropriate supervision:
Assisting in the coordination of cross-functional study teams through communications with clinical sites, sponsors, and vendors
Contributing to protocol development by drafting operational protocol sections, ensuring consistency throughout the document, coordinating reviews, and ensuring compliance with regulatory authorities
Assisting in the preparation, submission, and tracking of IRB materials
Developing and coordinating team review of training materials, procedural manuals, and other materials; tracking training completion
Facilitating and delivering components of study-specific training
Providing technical assistance and supporting clinical sites through:
Tracking site activation and performance, which may include study accrual, timelines, and close-out
Identifying and communicating potential problems
Working with sites post monitoring visit(s) on action items
Facilitating team meetings/calls including:
Writing and/or reviewing meeting minutes
Ensuring key decisions are documented
Tracking action items to resolution
Maintaining study files including:
Setting up and maintaining shared filing systems (e.g., SharePoint, MS Teams)
Developing and maintaining tracking tools (e.g., Excel/Word document tracker, study timeline)
Collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF])
Contributing to the study specific eTMF Management Plan
Drafting, reviewing, providing input on and/or finalizing documents, such as study progress reports and/or IDCRC specific work instructions.
Assisting Working Groups and Committees with meeting coordination, reviews, and other operations
Coordinating reviews of and providing input on abstracts, presentations, manuscripts, final study reports
Performing other duties as assigned
Supervision Given/Received:
Receives general instructions on routine work, and detailed instructions on new projects or assignments
Mentors Clinical Trials Assistants (CTA)
Does not have direct report/supervision responsibilities
Qualifications:
Bachelor's degree or its international equivalent in clinical research, health, behavioral, life or social sciences, or other related fields. Masterโs degree preferred.
Minimum of 2 years of experience in clinical research, or other research or healthcare-related field.
Basic knowledge of the conduct of clinical trials, related systems, and procedure.
Strong understanding of applicable clinical research regulatory requirements, e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and FDA regulations, to maintain site(s) essential regulatory documents per sponsor requirements.
Ability to work independently and in a cross-cultural team and geographically diverse environment.
Ability to prioritize and multitask, proactively follow up, effectively manage time, assess, meet and/or adapt to changing priorities and deadlines effectively, with strong attention to detail.
Proficiency in Microsoft Office 365 (i.e., Word, Excel, PowerPoint, Outlook, Teams) and familiarity with webinar platforms, such as Zoom.
Articulate, professional, and able to communicate in a clear, positive fashion with external partners and staff.
Ability to write clearly and succinctly; must be able to synthesize and summarize information.
Must be able to read, write, and speak proficient English.
Typical Physical Demands:
Typical office environment.
Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
Ability to sit or stand for extended periods of time.
Ability to lift or move up to 5 lbs.
Technology to be Used:
Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.
Travel Requirements:
Less than 10%
The expected US Based hiring salary range for this role is listed below. Candidate FHI 360 pay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI 360 factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, internal equity, business sector, and budget.
Base salary is only one component of our offer. FHI 360 contributes 12% of monthly base pay to a money purchase pension plan account. Additionally, all US based staff working full-time, which is calculated at 40 hours/week, receive 18 days of paid vacation per year, 12 sick days per year, and 11 holidays per year. Paid time off is reduced pro rata for employees working less than a full-time schedule.
US-Based Hiring Salary Range: $66,500 - $84,500
International hiring ranges will differ based on location
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
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