Senior Clinical Research Associate

Senior Clinical Research Associate

Premier Research

Remote, Portugal

What You'll be Doing:

• Delivering quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
• Maintaining submission of expenses according to travel and expense requirements within company guidelines
• Countrywide monitoring (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
• Planning day to day activities for monitoring of a clinical study and setting priorities per site
• Preparing for and conducting on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan
• Maintaining Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates

What we are searching for:

• Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
• Previous clinical research experience required, completion of CRA training program
• At least 4+ years independent monitoring
• We are looking for knowledge across a broad range of therapeutic areas so experience within at least some, if not, all of the following is needed; Cardiovascular, Oncology, Rare Diseases, CNS (Alzheimer's & Parkinsons Disease)
• There will be an expectation for countrywide monitoring - candidates will ideally be located in Porto & Lisbon and should be prepared for, on average, 6 days per month monitoring
• Hospital sites are located in Lisbon, Porto and Coimbra