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.
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
SCA is responsible for first time quality by self-check and reviews contracts for completeness and accuracy
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
Must be highly proficient in all the above accountabilities
Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of team's work products. Maintains and updates training material for site contract team
Be familiar with financial implications of the project and the number of hours/tasks available per contract and hours consumed; escalates discrepancies in a timely fashion
Acts as country expert by keeping up to date with country trends in site contracting and utilizing knowledge to inform and guide Site Contract Lead, other internal stakeholders, and study teams
