Site Contract Associate I/II
Taipei, Taiwan Job ID R0000029471 Category Clinical TrialsAbout this Role
Key Accountabilities:
• 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
• Ensure the best interest of both clients and Parexel are met
• 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
• Follow record maintenance and archival guidelines to ensure they are met
• Develop and maintain positive relationships with clinical trial sites
• 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
• Ensures that changes are appropriately made, approved and documented
• 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
• Reviews and complies with Standard Operating Procedures (SOPs) any other
relevant applicable guidance in a timely manner, keeps training records
updated accordingly and ensures timesheet compliance
• Ensure adequacy and accuracy of archived records
• Identify and implement process improvements to increase efficiency and
quality in the site contracting process
• Provide guidance and support to study teams and project management on site
contracting matters in the respective country
• Participate in cross-functional communication to identify process
improvements and contribute to the development of site contracting strategies
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