Freelance Senior Clinical Research Associate
$31,200–$31,200 year
RemoteLatvia
Job Summary
Monitor on-site and remotely clinical trials in accordance with GCP and ICH guidelines, assessing subject safety, data integrity, and protocol compliance. Verify informed consent procedures, review CRFs and source documentation for accuracy, and manage investigational product accountability. Submit Monitoring Visit Reports with findings and corrective actions, escalate deficiencies, and deliver site documents to eTMF or paper TMF. Maintain Investigator's Site Files and update CTMS with accurate site-level information. Participate in audit preparations and follow-up activities, order clinical investigative supplies, and assist in project tracking and CRA resource management. May conduct Assessment Site Visits, mentor CRAs, develop therapeutic area training, and facilitate discussions. Requires 5+ years of independent monitoring experience, fluent English, and willingness to travel up to 60-80%.
Required Qualifications
- Bachelor's Degree, preferably in life science or nursing
- >5 years of independent on-site monitoring experience
- at least 1 year experience as an unmasked monitor
- Able to work in a fast-paced environment with changing priorities
- Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas
- Possess the understanding of Good Clinical Practice regulations, ICH guidelines
- Ability to work independently as well as in a team matrix organization
- Excellent written and verbal communication skills
- Fluent in English and local language
- Excellent organizational skills
- Technology savvy and good software and computer skills
- Self-awareness
- resolute
- flexibility
- collaborative mindset
- proactivity
- analytic approach
- attention to detail
- coach ability
- motivated to take on new challenges
- facilitation of discussion
- diplomacy in difficult situations
- Ability to take the ownership of the assigned tasks
- Ability to manage complex or early phases studies
- Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable
Desired Qualifications
- At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.