Summary of the position:
The Site Management Associate coordinates and oversees all country-specific tasks associated with the start-up, maintenance, and closeout of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. This role includes collaborating with all functional departments and sponsor team members to provide site support during all phases of the clinical trial. This includes confirming site contact information for the Investigator Database, mentoring and training the Clinical Trial Associate or junior Site Management Associates, overseeing all needed preparations for site activation, and ensuring general regulatory maintenance.
The current document describes all the activities and responsibilities for the Site Management Associate position. However, because Site Start-Up is also a function within the project, this specific function may be delivered by employees with a different job title.
+ Proactively forecasts submission/approval timelines and ensures adherence. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.
+ May serve as the primary point of contact for the Project Manager or Study Start-up Lead (or designee) during start-up on allocated projects.
+ Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions during site start-up, maintenance and close out as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. May provide regular updates of country specific information on the clinical trial application database on SharePoint. Submits end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.
+ Ensures the site contract and budget are on track to meet the Site Initiation forecast timelines by liaising with the Contracts and Grants Manager until resolution of contract and budget issues and contract execution.
+ Prepares checklist for IP release/Site Activation according to country regulations.
+ Performs essential document collection and review during site start-up, maintenance and close out, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines
+ Ensures accuracy and completeness of trial master file documents submitted during site start-up, maintenance and close out. Performs routine QC review of site files in the TMF.
+ Complete tasks associated with the start-up, maintenance and close out of a site during the life cycle of a clinical trial. This may include varying tasks based on country, project requirements and applicable country rules and regulations. Task may include; essential document collection, review, and tracking, Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, site TMF maintenance and QC and dissemination of study supplies, as applicable.
+ Serves as primary liaison for study and site (post SSU completion) management issues, escalating to PM as required.
+ Responsible for the collection, review, tracking, maintenance and archiving of essential study documents in the Trial Master File., including the creation and maintenance of project-specific administrative documents (e.g., contact lists, study team roster, etc.). Assists clinical team with maintaining accurate updated clinical trial management systems (CTMS) that track site visits, compliance, and performance within timelines. Assists in the close-out of projects by performing a final Quality Control (QC) of the Trial Master File (TMF), identifying items and issues for review and/or follow-up by the CRAs and/or project management.
+ Responsible for preparing and maintaining study documentation and tools while ensuring that project-specific administrative documents (e.g., contact lists, study team roster, metric trackers etc.) are maintained. Assists with the drafting or review of organizational process tools and templates, study specific documents and plans such as informed consent forms, project management plans, regulatory documents, etc. Coordinate document translation as necessary.
+ Provides country-level intelligence for maintenance and close out. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
+ Works within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
+ Ensures that all site maintenance and close out tasks meet expectations and are delivered in accordance with the contracted timelines
+ Manages time and project requirements based on study contract.
+ Works with internal and external customers/vendors to meet project specific goals
+ Proficient in the development and review of Informed Consent Form templates
+ Provides input in local SOPs, Associated Documents, and Job Aides.
+ May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents.
+ Support for the creation of internal training materials on for local legislation requirements.
+ Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions.
+ Assists with mentoring and training staff.
+ All other duties as assigned.
Knowledge, skills and abilities:
+ Needs an intermediate level understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
+ Knowledge of ICH / GCP regulations
+ Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.
+ Knowledge of web-based communication tools for conferences and any other IT systems required for the job.
+ Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
+ Strong verbal and written communication and negotiation skills
+ Previous experience with database and clinical management systems.
+ Ability to prioritize and manage multiple tasks with demonstrated ability to meet deadlines.
+ Possess an understanding of medical and clinical research terminology
+ Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items.
+ Driven self-starter with the ability to begin tasks independently and complete tasks without supervision.
+ Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
+ Demonstrated effective organizational skills and strong attention to detail.
+ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
+ Customer-service focused in approach to work, both internally and externally
+ Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development.
Required Job-related Experience:
+ Four or more years of related experience in the submission of clinical trial applications, regulatory affairs, clinical research, or clinical operations environment.
+ Clinical Monitoring (remote or on-site) and Start-Up experience
+ Knowledge of ICH and local regulatory authority drug research and development regulations preferred
+ Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials. Knowledge of site and institution specific contract requirements
+ Proficiency in Microsoft Office and spreadsheets
+ Able to professionally communicate in a clear, positive fashion with clients and staff.
+ Ability to work independently without direction.
+ Ability to adapt to a fast-paced environment requiring flexibility and task prioritization
+ Must be able to read, write and speak fluent English.
Additional Eligibility Qualifications:
+ Experience with Trial Master File (TMF)
+ Experience with Clinical Trial Management Systems (CTMS)
+ Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Expected travel time is up to 10% for this position.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job description 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 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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