Tatiana Pedrosa

• Lead monitor (CRA) mentoring and supervising other monitor(s).
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• Ensure the resources of the Sponsor and CRO are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to CRO travel policy
• Ensure audit readiness at the site level
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Participate in and follow up on Quality Control Visits (QC) when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
• Might be requested to work in a client facing environment
• Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
• Independently perform CRF review; query generation and resolution against established data review guidelines on CRO or client data management systems as assigned by management
• Assist with training, of new employees, e.g. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management

• Clinical Research Associate I MEA (CRA I MEA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. In this position, candidates complete the Monitoring Excellence Academy (MEA) training program
• To provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP
• To develop and/or maintain tracking systems for clinical projects
• Responsible for all aspects of study site monitoring with or without direct supervision (as per the training status of the CRA I MEA). This includes remote and/or onsite conduct of pre-study visits, site initiation visits, routine monitoring visits and close-out visits of clinical sites
• Conduct site management activities, maintain study files, liaise with vendors; perform other duties, as assigned
• Responsible for aspects of registry management as prescribed in the project plans
• Managing and monitoring of clinical research projects according to SOP and ICH-GCP Guidelines. To conduct monitoring activities (remote or onsite) according to Monitoring Plan, such as to perform CRF review, SDR/SDV, Site Regulatory File Review, drug accountability, conduct site staff training. May assist and work under supervision of the primary monitor as required
• Ensure the resources of the Sponsor and organization are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy
• Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on organization or client data management systems, as assigned by management
• Track and follow-up on serious adverse events as assigned
• Travel, including air travel, may be required as per essential job
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Ensure audit readiness at the site level
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
• Independently perform CRF review; query generation and resolution against established data review guidelines on organization or client data management systems as assigned by management
• Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
• Travel, including air travel, may be required and is an essential function of the job

rovides support to Project Team and Clinical Operations Team

• Maintains working knowledge of protocols and Monitoring Plans for assigned projects
• Demonstrates good written and verbal communication skills
• Serves as primary contact for assigned research sites
• Verifies that the rights and well-being of trial subjects are protected
• Reconciles site regulatory binder assuring collection and completeness of regulatory documents
• May support translations of essential documents
• May support submission of trials to IRB/IEC and regulatory authorities
• Verifies that the investigator is enrolling only eligible subjects
• Ensures that sites have sufficient project specific supplies
• Attends and participates in team teleconferences and training
• Participates in site audits, as requested
• Participates in relevant trial meetings, e.g. Kick-off, Investigator and Monitor meetings
• May conduct site and study feasibility assessments
• May be involved in the development of monitoring guideline and tools
• Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Clinical Research
• Pays attention to signals of fraud, misconduct and escalates per Clinipace SOP
• Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines
• Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period
• Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan
• Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines
• Verifies that written informed consent was obtained before each subject participation in trial
• Verifies quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site
• Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records
• Verifies and supports recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and Monitoring Plan
• Manages investigative sites in respect to trial conduct and motivates sites to meet study goals
• Communicates deviations from protocol, SOPs, and/or GCP, to investigator, and project management team and takes appropriate action to prevent recurrence
• Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans
• Work according to the Clinipace Quality Management System and actively participate in giving feedback and suggesting improvements to current processes
• May provide input into study documentation and monitoring worksheets
• Uphold confidentiality agreements with all clients and colleagues outside Clinipace Clinical Research
• Work according to Clinipace Quality Management System and actively participate in giving feedback and suggesting improvements to current processes
• Work according to project-specific timelines and budget agreement, which has been agreed upon with sponsor. Accurately document time spent per project in Clinipace time allocation system
• Demonstrates flexibility and adaptability
• Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently
• Other duties as assigned by Clinical Operations Manager/Project Manager per project-specific requirements

• Screened patient records, databases and physician referrals to identify prospective candidates for research studies
• Maintained compliance with protocols covering patient care and clinical trial operations
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
• Collected data and followed research protocols, operations manuals and case report form requirements.
• Ensure that study procedures were carried out in compliance with protocol, GCP and applicable local regulations
• Support team at Site to check eligibility criteria for potential patients for study
• Ensure that CRA had access to documents requested for on-site and remote monitoring visits (including medical records, laboratory tests, ECG etc)
• Obtain missing data from medical team and/or clarification of any pending issues found during monitoring visits, making sure that queries were answered within expected time
• Assist data entry team, when necessary, as well as in resolution of "queries/ DCFs" according to requirements of study. Support site staff in coordination of study activities, including logistical planning and materials and medicines prepared for study
• Report protocol deviations immediately for Ethic Committee (EC), when applicable. Ensured that corrective measures were taken immediately after any deviation was observed, ensuring quality of study as well as safety and well-being of research participants