Indiana Stem Jobs

Mobile Indiana Career Connect Logo

Job Information

FHI360 Study Start Up Associate II in Indianapolis, Indiana

FHI 360 has a long history of supporting clinical research. In April 2019, our Global Research Services (GRS) operating unit became an independent, commercial organization named FHI Clinical Inc. FHI Clinical helps support and conduct clinical research in low-resource settings around the world. Our team includes clinical project managers, clinical research associates, research assistants, laboratory technologists, laboratory auditors, document specialists and instructional designers.

With culturally sensitive and multilingual employees in the United States, Africa, Asia, Latin America and Europe, FHI Clinical offers the following services to government and private sponsors:

  • Project management

  • Protection of participants’ safety and rights

  • Site identification, evaluation and development

  • Site monitoring, management and training

  • Research operations

  • Laboratory capacity building, auditing, and training

  • Logistical support

We seek competitive and entrepreneurial candidates to join our team. https://www.fhiclinical.com/

Job Summary:

The Study Start-Up Associate II 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 or Clinical Research 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.

  • Serve 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

  • 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.

  • 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.

  • Identifies, monitors, documents, and tracks out-of-scope activities

  • Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions

  • May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents and ICFs.

  • 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

  • May 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.

  • Assists with mentoring and training junior level staff.

  • Support for the 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:

  • Needs an intermediate level understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.

  • Knowledge of ICH / GCP regulations

  • Intermediate 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:

  • 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.

  • Acts 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:

  • Has no supervisory responsibility.

  • Receives instructions on new assignments.

  • Receives limited supervision on regular duties and responsibilities.

  • Provides instructions on new tasks and assignments to staff person.

  • Plans and manages own work.

  • Typically reports to a Manager.

Education:

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

Experience:

  • At least 2 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

Typical Physical Demands:

  • Typical office environment.

  • Ability to sit and stand for extended periods of time.

  • Ability to lift 5 - 25 lbs.

Technology to be Used:

  • Personal Computer, Microsoft Office 365 (i.e. Word, Excel, PowerPoint, e-mail), office telephone, cell phone and printer/copier.

Travel Requirements:

  • 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.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.

Please click here to continue searching FHI 360's Career Portal.

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.

As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.

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 never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org.

DirectEmployers