Senior Clinical Research Associate, Serbia

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits across Serbia and Croatia
• Ensure investigative sites comply with protocols, ICH-GCP, applicable regulations, SOPs and project requirements
• Act as primary contact for assigned sites and resolve questions, issues, action items and protocol deviations
• Review clinical trial data, source documentation and study systems for accuracy, completeness, data integrity and compliance
• Support site selection, activation, recruitment, study milestones and patient recruitment targets
• Train sites on protocols, study systems, processes and applicable requirements
• Maintain essential study documentation, including ISF and TMF
• Collaborate with sponsors, project teams, vendors and investigative sites
• Participate in audits, inspections, Investigator Meetings, study meetings and other project activities
• Mentor CRA I and II colleagues, participate in co-monitoring and CRA assessments, and contribute to process improvement

• Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline
• 4–6 years of relevant clinical research experience
• Strong clinical site monitoring experience from site start-up through close-out
• Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements
• Proficiency with EDC, IRT, eTMF, CTMS and Microsoft Office
• Strong understanding of site management, including site activation, recruitment, training, issue resolution and essential documentation
• Excellent communication, interpersonal and relationship-management skills
• Strong organisational, problem-solving and prioritisation skills
• Ability to work independently, exercise sound judgement and manage competing priorities
• Willingness and ability to travel approximately 40–60%
• Valid driver’s licence required
• Fluent written and verbal English
• Experience with Phase I–IV clinical trials, Medidata Rave or Oracle InForm, and mentoring junior CRAs preferred

• Education Reimbursement program for full-time employees
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility)
• One time office setup allowance for a scanner/printer, extra monitor, office furniture, etc.
• Working while visiting program – up to 4 weeks per year
• Flexible Summer Hours Program from May – September
• Employee referral incentive
• Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after 5 years of employment
• Optional formal mentorship program (Alimentorship)
• Country/region annual social events in person
• Leadership development programs for people leaders in accordance with seniority
• Social committee and other optional initiatives
• Additional benefits may be available depending on country of employment and local policies and eligibility