FHI 360 recruits a Study Start Up Associate III – Durham

Job Summary:

The Study Start-Up Associate III 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. This includes but is not limited to the following, conduct feasibility activities (CDA and Site Questionnaire Management), provide site contact information for the Investigator Database, coordinate with the Clinical Trial Associate to disseminate the Investigator Site File binders, essential document collection and review, tracking, site communications, Informed Consent review, Ethics Committees/Institutional Review Board submissions and communications, , protocol amendment management (if it occurs during study start up period), submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up, customs clearance and import/export license management, transition all study start-up complete sites to the Site Management Associate within timeline and in general all needed preparations for site activation.

Accountabilities:

  • Proactively forecasts submission/approval timelines and ensures they are adhered to. 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.
  • Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
  • 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
  • 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.
  • Serves as the primary point of contact for the Project Manager, Clinical Manager, Study Start-up Lead (or designee) during start-up on allocated projects. Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team
  • Serves as primary liaison for site start-up and site start-up management issues, escalating to SSUL and/or PM as required
  • Leads larger programs through study start-up and ensures that all site start-up tasks meet expectations and are delivered in accordance with the contracted timelines
  • Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
  • Local Investigator Contract and budget coordinator – liaises the Contract Management group to ensure the site-specific contract and budget has been submitted to the investigative site. Ensures the CTA timelines works with the expected and forecasted SSU timelines.
  • Prepares Site Activation checklist for IP release according to country regulations. May be requested to create the Site Activation Checklist for assigned projects.
  • Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
  • Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF
  • Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
  • Provides quality review of the informed consent forms (ICFs) and adapts the template as appropriate.
  • 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
  • Identifies, monitors, documents, and tracks out-of-scope activities
  • Serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents and ICFs.
  • Review and advise on Regulatory and Clinical Operations SOPs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
  • May have to assist with Study Start Up Plan development
  • Mentors and trains junior level staff.
  • Creation of internal training materials on for local legislation requirements
  • Maintain professional relationships with team members, Company staff and study site staff.
  • Set and meet personal and professional goals and objectives.
  • All other duties as assigned.

Applied Knowledge & Skills:

  • Thorough of level understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
  • Knowledge of ICH / GCP regulations
  • Thorough 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

Problem Solving & Impact:

  • Demonstrated ability to discuss strategic and sensitive issues.
  • Requires task orientation for projects but has a good understanding of how the task meets the deliverable objective.
  • Able to identify improvements in the process to meet the objective and/or recommend alternative tasks that meet objective.
  • Achieves quality and timeliness of objectives.
  • Exercises judgment within defined policies and procedures to obtain solutions and perform duties.
  • Decisions made generally affect own job or specific functional area.
  • Identifies potential or needed process improvements and recommends alternative courses of action.
  • Works on problems that are moderate in scope and exercises judgment to resolve them or to make recommendations as part of team.
  • Takes action to implement and correct plans to ensure goals are met within reasonable or defined timelines.
  • Adjusts priorities to meet changing business demands without losing focus on objectives.
  • Makes decisions that may affect cross-functional processes and other organizational areas.

Supervision Given/Received: 

  • Receives instructions on new assignments.
  • Typically reports to a Manager.
  • Receives limited supervision on regular duties and responsibilities.
  • May lead or supervisor other staff members.
  • Provides instructions on new tasks and assignments to staff person.
  • Plans and manages own work.

Education: Bachelor’s degree or its

  • Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development OR an Associate degree in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development with a combination of relevant experience.

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Experience: 

  • 3 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.

Technology to be Used:

  • Personal Computer, e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand held devices.
  • Strong computer skills (MS Office), Sharepoint, Acrobat and ability to work in FHI Clinical databases.
  • Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.
  • Ability to coordinate review and finalization of documents with multiple stakeholders.

Typical Physical Demands:

  • Typical office environment.
  • Ability to sit and stand for extended periods of time. * Ability to lift 5-50 lbs.

Travel:

  • * Less than 10%.

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.

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