This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.
The Clinical Research Associate role is accountable for performance and compliance for assigned protocols and sites in a country.
- Under the oversight of the Clinical Research Associate 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 for monitoring processes and systems.
Responsibilities include, but are not limited to:
- Performs clinical study site management/monitoring activities;
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities.
- 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.
- Conveys with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations;
- Contributes to Clinical Research Associate team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and disclosing best practices as appropriate.
- Promotes and/or guides audit/inspection activities as needed.
- Bachelor's degree in science and/or biology.
- Mininum 2 years of direct site monitoring experience in a bio/pharma/medical industry.
- Fluent in Spanish and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good comprehension and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good comprehension of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Proven Skills in Site Management, including management of site performance and patient recruitment.
- IT skills (Use of Microsoft Office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and evaluate data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner
- Availability to travel domestically approximately 65%-75% of working time. Expected travelling ~2-3 days/week. Current driver’s license.
Main Soft Skills Expectations:
- Effective time management, organizational and interactive skills, conflict management, problem solving skills.
- Able to work highly objectively across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works with high quality and compliance mind-set.