Site Relationship Partner (SRP)

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

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

• 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.

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

• For targeted sites

o 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

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 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

o Maintain a thorough knowledge of assigned protocols

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

o Support database release by facilitating query resolution, as needed

• 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

General

• 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

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