Candelaria Garcia Laborde

•Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs),
project requirements and contractual/budgetary guidelines. May also include maintenance activities.
•Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

• Manage assigned opportunities / projects / programs for country and adhere to timelines and budget.
• Generate sites list of appropriated investigators in accordance with the needs of the sponsor and with the specifications of the protocol.
• Coordinate collection and analysis of country Feasibility / Site Identification information to meet the timelines of proposal process and the independent Feasibility assessment.
• Utilizes historic site performance metrics, site relationships, feasibility data, and databases to identify sites.
• Contact Medical Advisors, RSU and Clinical Operations to develop a plan for identifying potential sites for assigned projects.
• Reconcile and interpret Feasibility/Site Identification data to provide country level assessments and recommendations for country site numbers, recruitment rates, timelines and screen failure rate.
• Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility and Site Identification with assistance from Manager/Legal Department, as appropriate.
• Distribute, track, negotiate and review Site Questionnaire for Feasibility and Site Identification for completeness, site capability and suitability of investigators.
• Tracks all project activities in CTMS.
• Responds to site questions about assigned studies in a timely manner. Manage the investigator database query and quality, ensuring complete investigator and site information is captured, and monitor for quality assurance.
• Maintain and update company information repositories and databases. Performs other duties as assigned.
• Lead and mentor team capabilities at country level.

• Collect, review, process, and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, ICH GCP guidelines, EU Clinical Trial Directive, FDA Regulations and the Investigator Package Plan
• Assist in review and approval of regulatory & investigator documents for study site activation and drug shipment trigger
• Assist in preparation of project specific plans for the GSS component of assigned studies
• Assist in review of core English patient informed consents for compliance to international requirements and protocol as applicable
• Assist in review of core Country patient informed consents for compliance to country requirements and protocol as applicable
• Assist in review of investigative site specific patient informed consents for required elements
• Maintain and update document tracking information in the Trial TrackerTM Site Information Module and other tracking logs
• Assess impact of site personnel changes on regulatory documents and Process/review new documents according to GCP/ICH guidelines
• Assess impact of study amendments on Informed Consent and other study documents and review and review accordingly
• Liaise with applicable IRB/IEC regarding investigator submission/approval issues as appropriate
• Setup and maintain investigative sites
• Understand and follow project specific and GSS policies and procedures
• Generate investigative site status reports for supervisor review
• Assemble administrative binders for study sites
• Perform other duties as assigned by management
• Assist in managing the drug supply vendor activities as applicable
• Assist in developing, review and approval drug supply labels as applicable
• Assist with the preparation and dissemination of feasibility documents according to the process in place
• Assume responsibility for identifying key therapeutic area investigators and consultants for external feasibility
• Develop and populate response spreadsheets
• Aid to summarize key therapeutic area information for inclusion in feasibility reports
• Assume responsibility for contacting and following with investigator sites regarding completion of confidentiality agreements and other information that may be required
• Design and generate standard and complex query reports from various data bases to support internal/client requests for information; develop and/or review time/cost reports for feasibility activities
• Responsible for identifying internal resources, locating critical historical data contained in feasibility and proposal archives, prioritizing requests for information from various internal databases and determining appropriate format for reporting same

• Assisted the clinical team in the preparation, handling, distribution,filing and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assisted CRAs/CRCs, CRAs/CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Might accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
• Might perform assigned administrative tasks to support team members with clinical trial execution.
• Prepared Investigator’s site files prior to site initiation visits.
• Attended TCs and meetings of the study with the project team.
• Sent study-related documentation and study materials to sites.
• Followed up of submission and approvals of study documents with sites.
• Collaborated with follow up of Payment Requests.
• Reviewed Central Investigator Files periodically.
• Performed updates to EIVIS and eFMF.
• Overall support to CRA team and sites.

• Contact with investigators and sites. Selection Process Capabilities and Feasibilities.
• Follow up with investigators and sites.
• Collection of CDAs and SIFs.
• Site selection process of sites and Principal Investigators.

• General office tasks.
• Take Phone calls
• Assistance in preparing draft reports for Gastric Biopsies
• Clinical records filing