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Category Clinical Trials
ABOUT THIS ROLE
In Parexel FSP we are looking for Site Relationship and Excellence Partner based in Turkey.
Position Purpose:
The Site Relationship and Excellence Partner (SREP) is the main Client point of contact for investigative sites as well as 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
As part of the oversight responsibilities, this role will utilize and 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
This role is also accountable for identifying Clinical Research Associate (CRA) performance issues and is responsible for ensuring appropriate corrective and preventative actions are put in place
The SREP is the face of Client and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Client’s reputation is that of Partner of Choice
The SREP proactively collaborates and provides local intelligence to country outreach surveys, targeted sites strategies, study design, and Client pipeline opportunities
This role 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 lead 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 SREP should be capable of performing both the Site Excellence Partner and the Site Relationship Partner role as dictated by need
Primary Duties:
- 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
- Demonstrate leadership within the local clinical development environment with a goal to enhance Client reputation in scientific leadership
- 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
- Review and manage site practices that differ from Client practices and liaise with study teams and study management
- Understand targeted site criteria as well as services delivered to target sites
- Track that all such services are provided consistently and in a timely manner
- Recommend potential targeted sites and conduct follow up with those sites as required
- Deploy Global Site and Study Operations (GSSO) targeted site strategy by qualifying and activating targeted sites, while coordinating Client functions to standardize processes and deliver activation in line with the targeted site strategy
- 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
- Provide enrollment support and ensure progress by responding to start up and recruitment issues from investigators, partner with study team to define and support recruitment initiatives at site/country level
- Maintain a thorough knowledge of assigned protocols
- Proactively identify, manage and escalate site issues related to study delivery, triaging and coordinating communications and resolution efforts by Client colleagues
- Support database release by facilitating query resolution, as needed
- 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 site and monitoring quality, regulatory and Good Clinical Practice (GCP) compliance
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution
- Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks
- 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.)
- Demonstrate use of data to enhance quality and accelerate study delivery
- Conduct and report oversight activities, both remote and onsite visits, according to Client requirements and standards
- Perform additional oversight visits/reviews based on the type of issues that arise during the course of a study, and the analytics and visualizations outputs. These may be conducted with the assigned CRA or alone depending on the nature of the issue(s)
- Work with CRO CRAs, and other CRO colleagues, to drive resolution of oversight issues
- 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) to address these
- Demonstrates the learning culture by ensuring site quality and trends, including preventive actions are shared across study & assets in the portfolio to drive accelerated drug delivery
- Identify potential improvements for Client processes
- Review of monitoring visit reports
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements
- Support local Investigator relationship management with the Site Relationship Partner
- Serve as point of contact for quality and safety escalations for CRO, CRAs, Site Relationship Partner and Study Team
- Support the resolution of operational obstacles at the site/country level in order to advance the site and study deliverables
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
- Adhere to EP and Client SOPs and processes
The Individual:
BS/BSc/MS/MSc or equivalent + 5 years of clinical research experience and/or quality management experience
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
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 skill
Demonstrated ability to manage projects and cross-functional processes
Ability to communicate effectively and appropriately with internal & external stakeholders
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 required
Fluent English is a must
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