Simara A. Email & Phone Number

- Mentors junior level CRAs and serves as a resource for new employees- Serves as observation and performance visit leader- May be assigned additional Clinical Operations tasks- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines- May be assigned clinical tasks where advanced negotiating skills are required- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely- Provides regular site status information to team members, trial management, and updates trial management tools- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed- Performs essential document site file reconciliation- Performs source document verification and query resolution- Assesses IP accountability, dispensation, and compliance at the investigative sites- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines- Communicates with investigative sites- Updates applicable tracking systems- Ensures all required training is completed and documented- Serves as observation visit leader- Facilitates audit s and audit resolution.

Natal, Rio Grande Do Norte, Brasil

- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely- Provides regular site status information to team members, trial management, and updates trial management tools- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed- Performs essential document site file reconciliation- Performs source document verification and query resolution- Assesses IP accountability, dispensation, and compliance at the investigative sites- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines- Communicates with investigative sites- Updates applicable tracking systems- Ensures all required training is completed and documented- Serves as observation visit leader- Facilitates audits and audit resolution- Reviews and verifies accuracy ofclinical trial data collected, either onsite or remotely;- Completes monitoring activity documents as required by SOPs;- Assesses IP accountability, dispensation, and compliance at the investigat ive sites.Verifies Serious Adverse Evet (SAE) reporting according to trial specifications and ICH GC Pguidelines.

Natal E Região, Brasil

- Participation in the selection of the center for new clinical studies; Knowledge of regulatory processes and monitoring the status of approvals in the CEP, CONEP, ANVISA and CONTRACT instances; - Monitoring of e mails and adm ini strative pen ding matters;- Deep knowledge NTRACof the Clinical Research protocol in order to explain the study to the recruitingpatient, as well as treatment, adverse events and the study design in general;- Planning of the study for which you are responsible , a s well as th e visits, patient visits, exams, filling out the CRF.

Natal, Rio Grande Do Norte, Brasil

- Good Nursing Practices; Regulatory Process;- Process Quality in Clinical Studies; Nursing consultatio n t o pa tients in clinical research protocol; Medication administration; Principles of safety in the administration of chemotherapeutic drugs; - Principles of safety in the administration of chemotherapeutic drugs; Care for cancer patients; Collection schedule for the export of biological samples; Collection, processing;- Oncology patient care, supervising the team, acting on infection control, as well as following up on patient safety.

- Good clinical practices; - Regulatory process; - Process quality in Clinical Studies; - Nursing consultation to patients in clinical research protocol.

Master Of Business Administration - Mba, Gestão Em Projetos

Especialização, Enfermagem Oncológica

Especialização, Docência Em Enfermagem

Bacharelado Em Enfermagem, Registered Nursing/Registered Nurse