Site Relationship Partner Job in Parexel International Corporation

• The Site Relationship Partner (SRP) is the main Client point of contact for investigative sites, responsible for building and retaining relationships from site activation through the lifecycle of studies
• The SRP is the face of the Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and the Client s reputation is that of Partner of Choice.
• The SRP proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities.
• The SRP is accountable for study start up, activation, and execution to the plan for targeted sites.
• In addition to being the main point of contact, the SRP will help coordinate with other roles and functions that will interface with target sites, thereby, simplifying site Client communications and enhancing overall visibility into and confidence of quality of site-level activities.
• The SRP may be required to support some or all of the primary responsibilities of the Site Excellence Partner (SEP), as example, safeguarding the quality and patient safety at the investigator site, responsible for site and monitoring oversight, and utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
• Additionally, the SRP may be required in identifying Clinical Research Associate (CRA) performance issues and responsible for ensuring appropriate corrective and preventative actions are put in place.

• Responsible for relationship building and management
• Usher investigator sites through site activation and study activities from study start up to close out.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Act as the main point of contact for all site- and study-level questions, liaising with and escalating to appropriate teams to respond and resolve questions. Follow up and close issue status with investigators to ensure awareness of resolution.
• Inform and educate investigator sites of Client pipeline opportunities that may be a good fit.
• Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
• Provide country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC) and medical practices.
• Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
• Confirm (and educate where needed) that sites are familiar with Client requirements for study start up and facilitate the availability of Master Service Agreements (MSAs) when feasible.
• Lead study start up activities at the site level, including management of issues that may compromise time to site activation.
• Closely monitor and support study start up activities including review of key documents (e.g., local Informed Consent Document template), to address regulatory and/or ethics committee questions for Targeted sites.

Qualifications

• A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology
• In general, candidates for this job would hold the following levels of education/experience: BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience.
• Skills in more than one language are an advantage in this role; English is required
• Experience with drug development and monitoring (preferred)
• Experience implementing centrally designed and developed initiatives on a local basis
• Demonstrated knowledge of quality and regulatory requirements for applicable countries
• Demonstrated knowledge of site intelligence at cluster level in support of site recommendation
• Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, Good Clinical Practice (GCP), Food and Drug Administration (FDA), or country-specific regulatory environment