- Draft, review and negotiate all site agreements including but not limited to clinical study agreements, service agreements, team member agreements and other types of related documents like letters, notices, etc.
- Provide context to comments received from sites in light of local legal and business framework, common practices, and past negotiation experience for the purpose of further review up the decisioning chain
- Apply and scrutinize site contract and related documents and their revisions against negotiation and budget parameters (as applicable)
- Ensure final documents comply with applicable laws, regulations, and guidelines, including ICH – GCP
- Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
- Manage the contract execution process, including obtaining required signatures and ensuring timely execution of the document by all parties
- Develop and maintain a thorough understanding of the clinical trial protocol, budget, and timelines to ensure that contract terms align with the overall trial goals and objectives
- Identify potential issues or concerns with contract terms and collaborate with internal stakeholders and clinical trial sites to find mutually acceptable solutions
- Stay up to date with relevant regulatory requirements, guidelines and applicable laws in respective country
- Identifies if all necessary documents, such as Power of Attorney, Insurance Certificates, Indemnification Letters, Informed Consent Form, referenced agreements or any other correlated documents are in line and in place for the need of Clinical Site Agreement
- Track and report on the statuses of site contracting activities to Site Contract Lead, other internal stakeholders and study teams
- SCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracy
- Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon contract tracking system in real time
- Identifies possible contract or process operational risk and proactively works with SCL to provide solutions
Education:
- Educated to the degree level (biological sciences, business, paralegal/law) or relevant clinical or business equivalent.
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Site Contract Associate II - Southeast, United States - Parexel
Description
Home Based, US
Parexel is seeking a Site Contract Lead with more than 6 years of experience in Clinical Research focusing on customization, negotiation and executing of Clinical Site Agreements as well as SRP collection and IRB/IEC and RA application, preparation, and submission, in accordance with relevant regulations, SOPs, and study specific procedures. Possess experience and knowledge as well as broad background in contracting and SSU activities of clinical trials in various indications.
Responsibilities:
