Job Overview
The Senior Clinical Research Associate I is responsible for site monitoring and site management. This role requires a thorough understanding of regulatory requirements, including basic knowledge of regulations in other countries. The ideal candidate will have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives, and follow-up of SAEs.
This position involves advanced site monitoring skills, study site management skills, and registry administration skills. The candidate must be able to work with minimal supervision and possess excellent communication skills. A valid driver's license is also required.
Responsibilities
* Responsible for all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors;
* Responsible for all aspects of site management as prescribed in the project plans.
Qualifications
* University or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology;
* In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered.
* Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries;
* Thorough understanding of the drug development process;
* Fluent in local office language and in English, both written and verbal.
Requirements
* Typically three (3) years of clinical onsite monitoring experience;
* Advanced site monitoring skills;
* Advanced study site management skills;
* Advanced registry administration skills;
* Ability to work with minimal supervision;
* Valid Driver's License.
Work Environment
Travel requirements: 60-80%
About the Role
This role is a mid-senior level position, requiring significant experience and expertise in clinical research. The ideal candidate will be highly motivated and have excellent problem-solving skills. They must be able to work independently and as part of a team, with a strong focus on delivering high-quality results.