Senior Clinical Research Associate
About this role
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
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.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
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 & Parkinson's 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.
Proficiency in spoken and written Spanish highly desirable in case of a need to perform some monitoring in Spain.
This is a contract / freelance position and is offered as a full FTE with a duration of up to 1-year. It is a fully home based position.
Originally posted on Himalayas