MG | Minas Gerais, GO | Goiás, DF | Distrito Federal
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Biotecnologista
Farmacêutico
Médico Veterinário
Responsibilities include, but are not limited to
- Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and externally;
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites;
- Actively develops and expands the territory for clinical research, finding and developing new sites;
- Participates in internal meetings and workstreams as SME for monitoring processes and systems;
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial;
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws;
- Regulations, Protocol, Site Monitoring Plan and associated documents;
- Gains an in-depth understanding of the study protocol and related procedures;
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready;
- Participates & provides inputs on site selection and validation activities.
Performs remote and on-site monitoring & oversight activities using various tools to ensure
- Data generated at site are complete, accurate and unbiased;
- Subjects’ right, safety and well-being are protected;
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner;
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out;
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance;
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed;
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites;
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines;
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required;
- Supports and/or leads audit/inspection activities as needed;
- Performs co-monitoring visits where appropriate;
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
Requeriments
- B.A./B.S. required with strong emphasis in life sciences, science in general and/or biology.
- Must be fluent in Portuguese and have advanced proficiency in English.
- Required previous experience in clinical research experience. Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.
- Required direct site management (monitoring) experience in a bio/pharma/CRO.