other
Posted 2 weeks agoSCRA / Site Engagement Manager - FSP
at Fortrea
Sydney, AustraliaHybrid
Responsibilities
- Enhance clinical trial investigators’ and their research staff’s awareness of and relationship with the Client (including highlighting publicly available information regarding the Sponsor’s mission, values, pipeline, etc.) through direct interactions with clinical trial investigators and their research staff as well as via other mechanisms (e.g., Sponsor’s website, social media, etc.) Function in accordance with the Client Code of Conduct, Standard Operating Procedures (SOPs)/Working Practices (WPs), and
- Develop tailored engagement plans and strategies for each investigator site to align with their specific needs and challenges.
- Analyse patient enrolment and retention methods to identify potential roadblocks and propose strategies to increase patient recruitment and/or retention rates at each site.
- Identify potential risks associated with site performance and escalate issues as needed to mitigate any negative impact on trial timelines and outcomes.
- Collaborate with cross-functional teams to ensure alignment of goals.
- Conduct/participate in site feasibility assessments/qualification visits (as applicable) and participate in Pre-Selection Visits (PSVs) and Site Initiation Visits (SIVs) with the CRAs to ensure the robustness of these assessments/visits and a thorough evaluation of the investigators’ and their clinical research staff’s capabilities to successfully conduct the trial according to the protocol and to achieve their subject recruitment and retention targets and share findings and recommendations with the
- Identify potential clinical trial investigators who are new to the Sponsor through a variety of sources, including prior
- Ensure patient safety and compliance with informed consent and protocol requirements.
- Review source documents and verify data integrity on Case Report Forms (CRFs).
- Prepare accurate and timely monitoring reports and maintain study files.
- Coordinate with vendors and internal teams to meet project timelines and objectives.
- Support feasibility assessments, budget negotiations, and regulatory submissions.
- Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities.
Requirements
- Serve as the primary point of contact between the organization and site personnel, while fostering a sense of partnership and mutual benefit to enhance long-term relationships with investigators and site staff.