Clinical Research Manager I
FHI 360 staff working in the United States are required to be fully vaccinated for COVID-19, regardless of the type of project or client they serve, or of their employment status (full/part-time, remote, telework, or in-office), unless an accommodation applies. FHI 360 complies with federal, state, and local laws with regard to accommodations related to this policy.
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, management, and conduct 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, coordinating study training, facilitating communications, managing study files, and coordinating study reporting, among other activities. All activities performed are under supervision by senior staff.
The CRM I assists in the management of one or more clinical studies, through the following activities, all under appropriate supervision:
- Assisting in the coordination of cross-functional study teams
- Communicating with clinical sites, sponsors, and vendors
- Monitoring key indicators for study quality and performance
- Contributing to protocol development including:
- Drafting operational protocol sections
- Ensuring consistency throughout the protocol document
- Coordinating reviews and collating comments and edits
- Ensuring compliance with regulatory authorities when writing and reviewing
- Assisting in the preparation, submission, and tracking of IRB materials
- Developing and coordinating team review of training materials and slides, 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
- Conducting site visits, including for site evaluation, initiation, assessment, and close-out
- Assisting in the creation and monitoring of study budgets, invoices, and contracts
- Forecasting, procuring, and distributing study supplies
- Preparing for and participating in audits by study sponsors or other oversight bodies
- 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, project management software tool)
- Collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF])
- Contributing to the eTMF Management Plan
- Conducting periodic Quality Control (QC) activities for document management
- Drafting, reviewing, providing input on and/or finalizing documents, such as:
- Study progress reports
- Policies and procedures (e.g., standard operating procedures [SOPs] and manuals of operation [MOPs])
- 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
Applied Knowledge & Skills:
- Basic knowledge of the conduct of clinical trials, related systems, and procedures
- Basic understanding of applicable clinical research regulatory requirements, e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and FDA regulations
- Basic understanding of budgets and contracts for invoice review
- Ability to work independently and in a cross-cultural team and geographically diverse environment
- Ability to work with marginalized and historically excluded populations
- 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 clients and staff
- Ability to write clearly and succinctly; must be able to synthesize and summarize information
- Must be able to read, write, and speak fluent English
- Bachelor's degree or its international equivalent in clinical research, health, behavioral, life or social sciences, or other related fields
- Master’s degree preferred
- Minimum of 2 years of experience in clinical research, or other research or healthcare-related field
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 and stand for extended periods of time.
- Ability to lift/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.
Or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job.
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.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.