Senior Clinical Research Associate manages and supports clinical trial sites and ensures that clinical trials are conducted in accordance with protocol and appropriate quality standards such as ICH-GCP, SOPs, applicable regulations and study guidance. Senior CRA acts as a mentor for less experienced colleagues.

Main Responsibilities:

• Maintains Trial Master File (eTMF) and is responsible for its accuracy and completeness.
• Closely cooperates with Start-up Specialists regarding EC and RA submissions and may assist with ICF creation or update.
• Independently performs site evaluation, training, monitoring and closure  visits and applies risk-based monitoring.
• Closely interacts with project team, local start-up team, contracts group and Line Manager.
• Is responsible for accurate and timely completion of reports, issues/deviation reporting and resolution.
• Participates in various work groups and performs other assigned tasks.

Qualifications:

• Master´s degree in medicine, pharmacy or life sciences.
• Previous experience on CRA position (on-site) at least 3 years as minimum;
• Excellent knowledge of ICF-GCP;
• Native Czech (or Slovak) speaker and advanced level of English (speaking and writing) are a must;
• Demonstrates exceptional PC skills (MS Excel, PowerPoint, Word, Outlook) and is experienced in using study systems (eCRF, IVRS, ePRO, CTMS);
• strong organizational skills, flexibility, detail-oriented;
• Drivers licence;
• Ability to travel up to 50% of time, including overnight travel.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.