09 nov
|
Premier Research
|
España
09 nov
Premier Research
España
Premier Research is looking for a Clinical Research Associate II to join our Clinical Monitoring, Site Management and SSU team. ¿Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. What You'll Be Doing Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines Maintains submission of expenses according to travel and expense requirements within company guidelines Monitors (remote, onsite, or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations Plans day to day activities for monitoring of a clinical study and sets priorities per site Prepares for and conducts on-site qualification, study initiation, interim monitoring,
and close-out monitoring visits at investigator sites as required by clinical monitoring plan Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. 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., or equivalent work experience required Previous clinical research experience required At least 2+ years’ experience in clinical trials and independent monitoring Experience working in Dermatology therapy area required Preference at working across all phases I-IV, although phase II and III only will be considered The role can be offered as fully remote, hybrid or office based, from Madrid. xqbhyrx There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.
📌 Clinical Research Associate (España)
🏢 Premier Research
📍 España