Senior Clinical Research Associate, Romania

• Independently perform, coordinate and oversee clinical site monitoring services
• Assess protocol and regulatory compliance according to standard processes, ICH/GCP guidelines and local regulation
• Serve as the primary liaison between the sponsor/Alimentiv and investigative sites
• Execute clinical study plans
• Provide guidance and mentoring to CRA I and II
• Conduct and document onsite and remote monitoring, close-out, qualification and initiation visits
• Review study data against source documents and resolve or escalate data queries
• Coordinate shipment and delivery of clinical supplies and study documents
• Train site staff on protocols, study plans, systems and ICH-GCP
• Manage site activation, recruitment milestones, site issues, action items and protocol deviations
• Review ISF, TMF and study systems for accuracy, timeliness and completeness
• Participate in investigator meetings, study meetings, audits and inspections
• Perform CRA Assessment Visits and co-monitoring visits
• Support hiring interviews, process improvements and best-practice development

• 4 - 6 years of related experience
• (Honors) Bachelor’s degree
• Fluent in written and verbal English
• Or an equivalent combination of education and experience may be considered
• Thorough knowledge of ICH-GCP and local regulatory requirements
• Proficient in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite
• Ability to travel up to 40-60%, depending on project assignment and geographic location of sites
• Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams
• Great communication and organizational skills, detailed orientation and sense of urgency
• Holder of a valid driver’s license
• Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr.CRA and/or ACRP Certification/Designation
• Experience with Phase I–IV clinical trials preferred

• Annual Bonus (Short Term Incentive Program) target = 8% of annual salary
• A monthly stipend of 400 RON (pro-rated based on hours of work) to offset business use of communication costs (internet, VoIP, land line, etc.)
• Monthly Cell phone stipend (RON 50)
• One time expense reimbursement of up to 500.00 (local currency) to purchase office items such as a scanner/printer, extra monitor, office furniture and supplies
• Mileage reimbursement for travel
• Home-based work arrangement