Job Description
Job Purpose:
The Site Care Partner (SCP) serves as the primary liaison for our client, ensuring that investigative sites receive comprehensive support and engagement. You will play a pivotal role in resolving issues, safeguarding the client's reputation throughout the study lifecycle, and ensuring the operational success of site-level recruitment and patient safety. As the main point of contact for investigative sites, your goal will be to build and maintain strong relationships from site recommendation through the entirety of the study process.
Key Accountabilities:
1. Intelligence Gathering
• Provide input into site recommendations based on an ******** understanding of country and regional site performance.
• Assist the Study Operations Manager (SOM) and Global Study Manager (GSM) in defining local requirements for investigational product shipments and supplies.
2. Study Start-Up and Activation
• Implement Global Site and Study Operations strategies by qualifying and activating assigned sites.
• Enhance country and site selection activities through review of potential site lists and providing Pre-Trial Assessment (PTA) feedback.
• Conduct essential study start-up activities, including the Informed Consent Document (ICD) finalization and Site Initiation Visit (SIV) management.
• Ensure follow-up activities post-PTA and SIV to confirm site readiness for First Subject First Visit (FSFV).
• Manage escalated site issues by coordinating communications and resolution efforts.
• Develop effective site recruitment plans that align with organizational targets.
• Maintain regular communication with investigator sites to monitor recruitment progress and provide timely updates.
• Collaborate with Regulatory Authorities and partners to ensure compliance and timely registrations.
3. Study Conduct and Closeout
• Act as the main point of contact for site-level queries, escalating to relevant teams as needed.
• Review site monitoring reports and support revisions or submissions of ICD documents.
• Coordinate with internal roles to maintain system management at the site level ensuring alignment.
• Conduct annual reviews of site assessments and update as necessary to maintain operational continuity.
4. Collaboration
• Foster open communication with SOM and support site monitors to develop positive investigator relationships.
• Coordinate with various roles interfacing with study sites to optimize communication and collaboration.
5. Process, Standards, and Oversight
• Utilize data from analytic tools to proactively identify risks and develop mitigation plans.
Skills:
• Minimum of 5 years' experience in site monitoring, particularly in Oncology.
• Proven track record in start-up, conduct, and study closeout activities.
• In-depth knowledge of regulatory requirements and quality standards.
• Strong computer skills and openness to new technologies.
• Exceptional ability to communicate effectively with stakeholders at all levels.
• Proven ability to adapt to evolving processes and technologies.
• Excellent verbal and written communication skills.
• Capability to build strong relationships with investigator site staff and stakeholders.
• Willingness to manage travel up to 75% regularly.
Education:
• Bachelor's Degree or Registered Nurse qualification.
EEO Disclaimer:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, ****** orientation, gender identity, national origin, disability, or protected veteran status.
The Site Care Partner (SCP) serves as the primary liaison for our client, ensuring that investigative sites receive comprehensive support and engagement. You will play a pivotal role in resolving issues, safeguarding the client's reputation throughout the study lifecycle, and ensuring the operational success of site-level recruitment and patient safety. As the main point of contact for investigative sites, your goal will be to build and maintain strong relationships from site recommendation through the entirety of the study process.
Key Accountabilities:
1. Intelligence Gathering
• Provide input into site recommendations based on an ******** understanding of country and regional site performance.
• Assist the Study Operations Manager (SOM) and Global Study Manager (GSM) in defining local requirements for investigational product shipments and supplies.
2. Study Start-Up and Activation
• Implement Global Site and Study Operations strategies by qualifying and activating assigned sites.
• Enhance country and site selection activities through review of potential site lists and providing Pre-Trial Assessment (PTA) feedback.
• Conduct essential study start-up activities, including the Informed Consent Document (ICD) finalization and Site Initiation Visit (SIV) management.
• Ensure follow-up activities post-PTA and SIV to confirm site readiness for First Subject First Visit (FSFV).
• Manage escalated site issues by coordinating communications and resolution efforts.
• Develop effective site recruitment plans that align with organizational targets.
• Maintain regular communication with investigator sites to monitor recruitment progress and provide timely updates.
• Collaborate with Regulatory Authorities and partners to ensure compliance and timely registrations.
3. Study Conduct and Closeout
• Act as the main point of contact for site-level queries, escalating to relevant teams as needed.
• Review site monitoring reports and support revisions or submissions of ICD documents.
• Coordinate with internal roles to maintain system management at the site level ensuring alignment.
• Conduct annual reviews of site assessments and update as necessary to maintain operational continuity.
4. Collaboration
• Foster open communication with SOM and support site monitors to develop positive investigator relationships.
• Coordinate with various roles interfacing with study sites to optimize communication and collaboration.
5. Process, Standards, and Oversight
• Utilize data from analytic tools to proactively identify risks and develop mitigation plans.
Skills:
• Minimum of 5 years' experience in site monitoring, particularly in Oncology.
• Proven track record in start-up, conduct, and study closeout activities.
• In-depth knowledge of regulatory requirements and quality standards.
• Strong computer skills and openness to new technologies.
• Exceptional ability to communicate effectively with stakeholders at all levels.
• Proven ability to adapt to evolving processes and technologies.
• Excellent verbal and written communication skills.
• Capability to build strong relationships with investigator site staff and stakeholders.
• Willingness to manage travel up to 75% regularly.
Education:
• Bachelor's Degree or Registered Nurse qualification.
EEO Disclaimer:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, ****** orientation, gender identity, national origin, disability, or protected veteran status.
💡 Quick Summary
Seeking a career-building opportunity? The Lead Clinical Research Associate - Site Care Partner position is now open for candidates interested in the Health Jobs sector. This role in Atlanta offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.