Site Relationship Partner (FSP)

Job Description

Position Purpose:
• 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

Primary Duties:
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

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
• Review and manage site practices that differ from Client practices and liaise with study teams and study management
• Recommend potential targeted sites and conduct follow up with those sites as required.
Accountable for study start–up, activation, and execution to plan

For targeted sites
o 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
o Lead study start up activities at the site level, including management of issues that may compromise time to site activation
o 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

For all sites
o Proactively identify, manage and escalate site issues related to study delivery, triaging and
coordinating communications and resolution efforts by Client colleagues

Responsible for CRO and Study Management Interface
o 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 (SEP) and Study Management

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 country/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
• 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
• Seeks to develop an integrated view of key colleague issues to shape decisions and strategy development
• Proactively manages change by identifying opportunities and coaching self and others through the
change
• Demonstrated ability to introduce new ideas and implement them
• Effectively overcoming barriers encountered during the implementation of new processes and systems
• Identifies and builds effective relationships with customers and other stakeholders
• Works well across country boundaries, respecting communication, and cultural differences in
interpersonal relationships
• Availability to travel regularly within country and region is required
• Effective verbal and written communication skills in relating to colleagues and associates both inside
and outside of the organization

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life–saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That s Parexel. We re a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn , YouTube , Facebook , Twitter , and Glassdoor .