Study Start-Up Specialist II
hace 11 horas
**Job Summary**
We are seeking a highly skilled Study Start-Up Specialist II to join our team at IQVIA. As a key member of our start-up team, you will be responsible for ensuring the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED), and Investigator Site Files (ISF) during the start-up process.
**Key Responsibilities**
- Provide updates during weekly client teleconferences, client meetings, and internal team meetings.
- Liaise with Clinical Monitoring, Site Contracts, Regulatory Affairs, and other interdepartmental team members 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, reviewing the protocol and seeking expertise from applicable supporting functions.
- Work with Project Managers to obtain client approval of the study-specific feasibility questionnaire, as needed.
- May support the ISSC Lead/Manager in working with clients to obtain/agree to study-specific Confidential Disclosure Agreement (CDA) Templates.
- May distribute CDAs and feasibility questionnaires to sites and follow up with sites accordingly to ascertain interest and meet study timelines.
- May review and negotiate CDAs according to country-specific requirements, seeking legal/management review when required.
- Sends regulatory packets to selected sites and documents/follows up with sites on the start-up process.
- Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required.
- Supports sites to answer any questions required for their local IRB/ethics committee submissions.
- Serves as IQVIA Biotech liaison with Central Ethics Committees (CECs), Institutional Review Boards (IRBs), Research Ethics Boards (REBs), and Ethics Committees (ECs), as applicable.
- May create, review, negotiate, and customize country/site-specific Informed Consent Forms (ICFs) and follows up with sites and sponsors accordingly.
- Contacts sites directly, or through local representatives, 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 teams to secure authorization of site contracts.
- Coordinate document translations required for CEC/EC submissions, as needed.
**Requirements**
- Strong understanding of regulatory compliance and clinical trial start-up processes.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Strong analytical and problem-solving skills.
- Proficiency in Microsoft Office and other relevant software applications.
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