Job Description
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.
Summary of the Position:
The Site Start-Up Lead (SSUL) performs all country specific tasks associated with the start-up of a clinical trial in accordance with all applicable regulations, standards, and study-specific requirements. The SSUL is responsible for working directly with Investigative Sites to independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review, essential document package review and provide updates to sponsor to teleconferences. The Lead must have an in-depth understanding of study start-up activities and associated regulatory requirements and be able to mentor and train Site Start Up Associates.
Essential Functions:
- Develops feasibility strategies in varying clinical studies, assessing areas such as site locations, patient enrolment, probability of success etc. using analytical tools and models to assist in feasibility assessments.
- Capable of performing all the activities and responsibilities with direction of the Global Site Management Operations: Director, Associate Director, or designee as follows:
- Execute study start-up for assigned protocols within Sponsor timelines by identifying clinical team needs, contracting and managing vendor supported tasks and tracking critical timelines.
- Monitor project plans and communicates and troubleshoots the leading and lagging indicators to meet Site Initiation Readiness.
- Ensure the accuracy and quality of site start-up deliverables by reviewing deliverables in reference to Company standards.
- Review and report on deliverables of vendors.
- Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions 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.
- Provides country-level intelligence on site start-up. 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.
- Provides data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This will typically include the Principal Investigator/Informed Consent and the CDA/contract template.
- Manage information sharing (i.e. Site Start-Up tracker, Site Identification TrackingTools).
- Assist with the development of Standard Operating Procedures and Associated Documents to document and communicate unit’s processes and procedures.
- Actively share new ideas for efficient and seamless processes during study team meetings.
- Provide agendas, meeting minutes and manages follow up items for all Site Start-Up meetings that are assigned.
- Follow standard processes for the collection and processing of study site start-up documents and site start-up information.
- Proactively inform manager of down-turns in leading site start-up indicators.
- Provide oversight and direction to clinical team and vendors related to site start up tasks by overseeing timely delivery of regulatory documents, reviewing documents for quality, providing feedback on quality of vendor deliverables and providing direction to vendor on task requirements and prioritization.
- Attend clinical team and operational team meetings and provides updates on the timely execution of inter and intra-departmental milestones.
- Mentors and trains junior SSU staff to improve quality of outcomes and to maintain team morale.
- Maintain professional relationships with team members, Company staff and study site staff.
- Set and meet personal and professional goals and objectives.
- Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and follows FHI Clinical and sponsor SOPs, metrics and FHIC quality requirements.
- Proficient in the development and review of Informed Consent Form templates.
- 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.
- All other duties as assigned.
Knowledge, Skills and Abilities:
- 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.
Position Requirements:
Education:
- 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.
- 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 electronic Trial Master File (eTMF)
- Experience with Clinical Trial Management Systems (CTMS)
- SharePoint
Physical Expectations:
- Typical office environment. Ability to sit and stand for extended periods of time; ability to move 5- 15 lbs.
Travel Requirements:
- 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 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.
Note: This position is open until filled.
