São Paulo, São Paulo, Brazil
Act as a CRA from qualification through close out. Working under contract for global pharmaceuticals. International experience in Australia and New Zealand.
Sr CRA acting as lead site, conducting site management activities for oncology and hematology studies.
- Desing CRF, protocol and brochure. Review study publication. - Conduct study feasibility and site qualification activities; -Assist with investigator meeting activities including organization, preparation and attendance. -Conduct site management activities after appropriate training including, but not limited to site qualification visit, site initiation visit, site training, site interim monitoring visit, and site close out visit. -Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines. -Establish and maintain good rapport with study sites. -Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines. -Coordinate timely shipment of clinical supplies and study drug to sites. -Ensure proper storage, dispensation and accountability of clinical supplies and study drug. -Maintain adequate site tracking records. -Follow-up of drug safety issues and safety reports in timely manner. -Communicate site study issues, concerns, and progress to Project Manager, Clinical Team Lead, and Clinical Research Manager accordingly. -Assist with the implementation of corrective actions when appropriate. -Assist in data clarification process. -Perform telephone monitoring activities in order to obtain study status information. -Prepare /review all patient tracking records. -Input and maintain study information concerning status of financial reimbursement to sites, as applicable. -Conduct and assist with administrative activities as member of the project team. Eg: negotiating of site contract budget, fill Datasheet paymentsas as member of the project team. -Participate in routine study progress meetings, face to face or via teleconference.
CRA activities conducting visits from qualification until close out focused in hematology and oncology studies.