Site Activation Partner I-FSP

Site Activation Partner (SAP)

Position Purpose:

• The Site Activation Partner (SAP) is responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Client standards
• The SAP will provide technical and logistical support to the Site Relationship Partners (SRPs) to deliver Investigator Initiation and Study Start Up

Organizational Relationships:

• Reports to ExecuPharm/Parexel FSP-assigned Line Management with day-to-day direction from Client; refer to Organizational Chart for details regarding assigned role and associated reporting structure
• Liaises with cross-functional lines as appropriate: Global Site and Study Operations (GSSO), Clinical Development and Operations (CD&O), Regulatory Affairs, Pharmaceutical Sciences, Medical Quality Assurance, Legal, and Drug Safety Unit

Primary Duties:

Responsible for supporting the SRPs and investigator for Targeted Sites:
Clinical Trial Site Activation & Conduct

• Assist with study site activation activities to ensure timely site activation
• Register investigator sites in Client registries, as required
• Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
• Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status
• Support local IRB workflow from submission through approval and support reporting of updates to safety information
• Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, Food and Drug Administration (FDA) 1572 revisions, for internal regulatory approval within required timelines
• Communicate site approvals to the SRPs, Study Start Up Project Managers (where applicable) and relevant study team members
• Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed
• Work with investigator sites throughout the study to complete required ongoing study documents such as documents for protocol amendments and FDA 1572 revisions.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
• Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
• Problem solve identified issues with appropriate timely escalation to the Site Relationship Partner (SRP)
• Assist the SRP with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Support investigator sites, SRPs, Study Managers and study teams in preparation for and providing

responses to site audits/inspections

Communication

• Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation
• Maintain ongoing contact and communication with the GSSO team members as needed.
• Respond promptly to GSSO team member and investigator site requests
• Establish tools for efficient updates to the GSSO Study Team members as needed regarding site

status, issues, delays, and approvals

Clinical Trial Monitoring Support

• As needed, support the SRP with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices (GCPs), and Client standards
• In collaboration with the SRP, conduct or oversee investigator site activation activities, IIP completion, site budget and contract negotiation, and ensure timely management of emerging issues that may compromise time to site activation
• In collaboration with SRP and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issues
• In support of the SRP, conduct remote monitoring activities, with a focus on Trial Master File/Site Master File reconciliation, investigational product reconciliation or other technical or logistical supportive activities that facilitate inspection readiness
• Identify and resolve, in collaboration with SRP, investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
• Assist to resolve data queries within required timelines; support database release as needed for

supported sites/functions

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

Skills and Education:

• School diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferred
• In general, candidates for this job would hold the following levels of education/experience:

• 2 years relevant experience in clinical site management

• Experience in study activation and site management is an asset

• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

• Must be fluent in English, and the regulatory language of the appointed location

• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of a clinical trial (e.g., study startup, conduct, close-out activities, reporting, etc.)
• Understand the quality expectations and emphasis on right first time
• Demonstrate compliance with all applicable company, regulatory and country requirements
• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.