FSP Site Relationship and Excellence Partner (SREP)

Site Relationship and Excellence Partner (SREP)

Position Purpose:

• The Site Relationship and Excellence Partner (SREP) is the main Client point of contact for investigative sites and accountable for safeguarding the quality and patient safety at the investigator site

• This role is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies

• Interpret 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

• Accountable for identifying Clinical Research Associate (CRA) performance issues and ensuring appropriate corrective and preventative actions are put in place

• This role is accountable for study start up, activation, and execution to the plan for targeted sites.

• The SREP should be capable of performing both the Site Excellence Partner and the Site Relationship Partner role

Primary Duties:

Responsible for relationship building and management

• Usher investigator sites through site activation and study activities from study start up to close out

• Act as the main point of contact for all site- and study-level questions

• Follow up and close issue status with investigators to ensure awareness of resolution

Responsible for proactively providing local intelligence

• 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

Accountable for study start-up, activation, and execution to plan for targeted sites

• Deploy Global Site and Study Operations (GSSO) targeted site strategy by qualifying and activating targeted sites, coordinate Client functions to standardize processes and deliver activation in line with the targeted site strategy

• Confirm that sites are familiar with Client requirements for study start up and facilitate the availability of Master Service Agreements (MSAs)

Responsible for CRO and Study Management interface

• Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Excellence Partner and Study Management

Responsible for process, standards, and oversight

• Responsible for site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance

• Drive inspection readiness and provide support for site audits/inspections

• Responsible for site and monitoring quality using and interpreting signals identified by Signal Interpretation Leads in conjunction with local country intelligence to proactively identify risks

• Lead risk assessment at the site/country level for their studies, including identifications of mitigation and control

• Maintain knowledge of appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.)

• Apply knowledge of data and analytics to target site and study, recommend and implement actions for mitigation and control

• Conduct and report oversight activities, both remote and onsite visits

• Accountable for identifying site and CRA performance issues and quality events and other quality issues at patient and/or site level, escalating, and supporting implementation of Corrective and Preventative Actions (CAPAs)

Protocol Site Oversight

• Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations

• Attend Investigator meeting/protocol training

Site and Study Management Interface

• Support local Investigator relationship management with the Site Relationship PartnerQualificationsSkills and Education:

• 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

• Solid knowledge of clinical development processes with strong emphasis on monitoring

• Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance (preferred)

• Site Management/Monitoring (CRA) experience (preferred)

• Project management experience preferred in the clinical development area

• Ability to lead, troubleshoot and influence for delivery

• Independent approach

• 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 country/cluster level in support of site recommendation

Demonstrated knowledge of clinical trial methodology and the drug development process, related to monitoring clinical trials, GCP, Food and Drug Administration (FDA), or country-specific regulatory environment

• Demonstrated success in prior scientific/technical/administrative roles

• Demonstrated experience in site activation

• Demonstrated networking and relationship building skills

• Demonstrated ability to manage projects and cross-functional processes

• Ability to communicate effectively and appropriately with internal & external stakeholders

• Ability to adapt to changing technologies and processes

• Ability to evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk

• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

• Considers stakeholders including regulatory agencies and marketing when developing strategies and future directions

• Challenges people to surpass themselves in reaching their objectives using innovative solutions

• Utilizes and encourages innovative approaches to build and maintain a competitive advantage

• Acts as a champion of change across the area/region/countries; uses facts, logic and personal credibility to influence the successful implementation of process improvements

• Builds wide networks and alliances; utilizes stakeholder input to develop strategic thinking and find opportunities for collaboration

• Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards

• Exhibits behaviors consistent with company values to colleagues at multiple locations with diverse cultures

• Motivates through example, commitment, loyalty and enthusiasm

• Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development

• Demonstrated ability to introduce new ideas and implement them

• Effectively overcoming barriers encountered during the implementation of new processes and systems

• Works well across country boundaries, respecting communication and cultural differences in interpersonal relationships

• Availability to travel regularly within country and region is requiredEEO DisclaimerParexel 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, sexual orientation, gender identity, national origin, disability or protected veteran status.