Site Activation Partner II (FSP)

Parexel International Corporation

Czech Republic - Any Region - Home Based

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 standardsThe SAP will provide technical and logistical support to the Site Relationship Partners (SRPs) to deliver Investigator Initiation and Study Start UpOrganizational Relationships:Reports to ExecuPharm-assigned Line Management with day-to-day direction from Client; refer to Organizational Chart for details regarding assigned role and associated reporting structureLiaises 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 UnitPrimary Duties:

Responsible for supporting the SRPs and investigator for Targeted Sites:

Clinical Trial Site Activation & ConductAssist with study site activation activities to ensure timely site activationRegister investigator sites in Client registries, as requiredSupport 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 statusSupport local IRB workflow from submission through approval and support reporting of updates to safety informationFollow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely mannerPrepare, 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 timelinesCommunicate site approvals to the SRPs, Study Start Up Project Managers (where applicable) and relevant study team membersAssist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as neededWork 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 flowSubmit 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 proceduresClinical Trial Monitoring SupportAs 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 standardsIn 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 activationIn collaboration with SRP and Outsourcing Lead, facilitate site payments as needed and as per contracts and work with the appropriate groups to resolve issuesIn 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 readinessQualificationsSchool diploma/certificate or equivalent combination of education, training and experience; BS/BA or Bachelor’s degree in life sciences preferredIn general, candidates for this job would hold the following levels of education/experience:2 years relevant experience in clinical site managementExperience in study activation and site management is an assetKnowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulationsMust be fluent in English, and the regulatory language of the appointed locationDemonstrated knowledge of clinical research and development processes and ability to gain command of process detailsDemonstrated knowledge of global and local regulatory requirementsDemonstrated 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 timeDemonstrate compliance with all applicable company, regulatory and country requirementsAttention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.Proven ability to work independently and, also as a team memberAbility to organize tasks, time and priorities, ability to multi-taskUnderstand basic medical terminology, GCP requirements and proficient in computer operationsEffective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organizationRequired to support multi-national team members, and flexibility in working hours may be needed occasionally

2021-05-03 00:05:20

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