Key Responsibilities
- Act as the main point of contact and support for the assigned investigational sites.
- Prepare, conduct, and report remote and onsite monitoring visits in accordance with the Monitoring Plan and applicable SOPs.
- Assess investigational site performance and ensure compliance with study protocol, GCP, and regulatory requirements.
- Perform all required activities during monitoring visits according to internal and/or sponsor procedures.
- Document and track the management of issues and deviations identified during and between site visits.
- Support investigational site staff in the resolution of issues/deviations and the development of Corrective and Preventive Action (CAPA) plans.
- Collaborate with Biometry, Regulatory Affairs, and Safety departments to obtain necessary site documentation.
Key Interfaces
- All departments within the Operations area.
Education
- University degree in Medicine, Biology, Biochemistry, Pharmacy, Nursing, Psychology, Chemistry, or other life science fields.
- Master’s degree in Clinical Study Monitoring or an equivalent qualification.
Training Requirements
- Solid understanding of Good Clinical Practice (GCP).
- Knowledge of the regulatory framework governing clinical studies.
- Understanding of data protection regulations applicable to clinical research.
Experience
- Minimum 1 year of experience in a similar role within clinical trials or internship experience in clinical research.
- Candidates with strong interest in clinical trials will also be considered; training and mentorship will be provided.
- Desirable experience in clinical investigations with medical devices.
- Desirable experience using electronic platforms, including eCTMS and eTMF.
Languages
- Spanish
- Advanced English level (spoken and written).
Other Requirements
- Ability and willingness to travel, both domestically and internationally.
Core Competencies & Skills
- Knowledge of established quality standards and ability to follow internal instructions.
- Proactive attitude with a willingness to contribute to continuous improvement.
- Familiarity with cloud-based IT platforms and digital tools.
- Strong communication, reporting, and interpersonal skills.
- Comfortable working within multidisciplinary teams.
- Excellent organizational skills, independence, and strong time-management abilities.
- Effective active listening and negotiation capabilities.
- Rigorous, detail-oriented, and problem-solving oriented.
- Sound decision-making and ability to manage complex situations.
