CLINICAL STUDIES PHYSICIAN - 53388 Bogotá

They will be responsible for executing activities related to the development of high-complexity clinical studies, ensuring compliance with institutional policies and applicable national and international regulations. Likewise, they will support the training strategies of the research center, in order to ensure the safety of participants and the quality, integrity, and reliability of the information collected during the execution of the projects.

Education

Undergraduate degree in MEDICINE

Technical Knowledge

General medical knowledge in outpatient consultation and hospital services, preferably in internal medicine and oncology services. Previous experience in research centers as an investigator in pharmaceutical industry trials is valued but not required; basic knowledge in technical procedures; Administrative aspects: Quality management system, biosafety, quality control. Proficiency in office tools (word, excel, powerpoint, drive, mail, IA, etc.). Management of information systems used in clinical studies (RedCaps, Oracle, Inform, Rave, among others) - Desirable. Can be learned during the development of the contract. Intermediate English.

Specific Work Experience

1 year as a General Physician - Ideally with experience in the clinical field.

Roles and Responsibilities of the position (A)

Support the preparation of high-complexity clinical studies, identifying operational, technical, and regulatory requirements for their safe and efficient execution. Participate in the preparation and review of feasibility documents, budgets, contracts, manuals, and support material, as well as in the training and initiation activities defined by the sponsor, in order to guarantee the proper development of the research protocols. Support the conduct of clinical studies through the identification, monitoring, and accompaniment of participants, verifying selection criteria, documentation, and compliance with the activities defined in the protocol. Participate in visits, clinical monitoring, information recording, resolution of findings, and reporting of adverse events or deviations, guaranteeing patient safety and the reliability of the study data. File and safeguard clinical study documentation, ensuring the preservation, confidentiality, and controlled access of source documents and records required by the sponsor and current regulations, in accordance with institutional guidelines and Good Clinical Practices. Attend and accompany monitoring, audit, and inspection visits of the clinical studies, timely managing identified findings and supporting the implementation of corrective and improvement actions, with the purpose of guaranteeing the quality, integrity, and reliability of the study information. Comply with the activities defined in the Quality System of the research center, participating in indicator reporting, incident management, audits, committees, and continuous improvement activities, in order to strengthen compliance with processes and the Good Clinical Practices applicable to research.