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Sr Study Start-up Specialist

hace 3 semanas

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**BASIC FUNCTIONS**:
Responsible for the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) during start-up. Work with both internal and external teams to assure good communication, regarding documentation processing. Assure documents maintained are following International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. A Sr. SSUS may be assigned to one or more start-up projects and is able to work independently on a project with mínimal supervision.

**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:

- Leads SSU activities and updates during weekly client teleconferences and internal team meetings.
- Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.
- May provide a role in the coordination of the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.
- May create and disseminate Confidential Disclosure Agreements (CDAs)/ Questionnaires to sites and follow up accordingly to ascertain interest and to meet study timelines.
- May review CDAs on behalf of sponsor according to country and sponsor specific requirements, seeking legal/management review when required.
- May create, review, negotiate and customize country/site specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
- Assists sites and/or leads a team with local IRB/ethics committee submissions.
- Serves as IQVIA Biotech liaison with central IRBs/REBs/ECs, as applicable.
- Creates templates for regulatory documents specific to local and central Institutional Review Board (IRB) /ethics committee submission requirements. Assembles and distributes regulatory documents to sites either directly or through local CRAs in specific countries.
- Contacts sites directly, or through local representative (country dependent), as required to resolve issues before CEC/IRB/REB/ethics committee submission and final review.
- May prepare and negotiate Clinical Site Contracts for site locations in some countries outside of North America.
- Liaise with legal and internal team to secure authorization of site contracts.
- Coordinate document translations required for CEC/EC submissions, as needed.
- Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA), CEC and Ethics Committee (EC) submission documentation, and similar information for other related organizations, for the assigned countries.
- Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
- Notifies the Regulatory Advisor representative (RA-R) when initial essential documents are available for review. Works with the RA-R to resolve any concerns.
- Manages quality and regulatory compliance documentation among investigational sites.
- Adheres to study timelines, documents study challenges and communicates updates to Project Manager and SSU Lead/Management.
- Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
- Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study.
- Assures that team members understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget.
- Identifies out of scope activities to SSU Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided.
- Participates in financial and/or resource forecasting, as applicable.
- Responsible for transitioning sites from SSU to File Maintenance representative.
- Update study start-up timeline tool, per IQVIA Biotech SOP.
- Participates in reviewing Safety and Regulatory management plans.
- Leads in training and development of junior staff.
- Mentors junior staff.
- Performs other duties as required.
**KNOWLEDGE, SKILLS & ABILITIES**:

- Knowledge of clinical research process related to study start-up and medical terminology.
- Knowledge of Regulatory and Central/Local ethic submission processes for assigned countries.
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
- Excellent organizational and interpersonal skills with track record for attention to detail.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
- Ability to manage