Clinical Research Associate II

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. Understands 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

• At least 2+ years’ experience in clinical trials and independent monitoring

• Experience working in one or more of the following therapy areas will be beneficial; Neurology, Oncology, Rare Diseases & Pediatrics

• 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.  There will be an expectation for country-wide monitoring with the average frequency of days on site being 6 days per month.