Senior Clinical Research Associate, Serbia

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Conduct and document onsite and remote monitoring activities independently, including site qualification, initiation, monitoring, and close-out visits across Serbia and Croatia.

• Ensure that investigative sites adhere to protocols, ICH-GCP, relevant regulations, SOPs, and project requirements.

• Serve as the primary point of contact for assigned sites, addressing questions, issues, action items, and protocol deviations.

• Review clinical trial data, source documentation, and study systems to ensure accuracy, completeness, data integrity, and compliance.

• Assist in site selection, activation, recruitment, study milestones, and patient recruitment targets.

• Educate sites on protocols, study systems, processes, and applicable requirements.

• Maintain essential study documentation, including the Investigator Site File (ISF) and Trial Master File (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, engage in co-monitoring and CRA assessments, and contribute to process improvements.

⛳️ Requirements

• Bachelor's degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing, or a related field.

• 4–6 years of relevant clinical research experience.

• Strong clinical site monitoring experience from site start-up through to close-out.

• Comprehensive knowledge of ICH-GCP, clinical research principles, and applicable local regulatory requirements.

• Proficient in EDC, IRT, eTMF, CTMS, and Microsoft Office.

• Solid understanding of site management, including activation, recruitment, training, issue resolution, and essential documentation.

• Excellent communication, interpersonal, and relationship management skills.

• Strong organizational, problem-solving, and prioritization abilities.

• Capacity to work independently, exercise sound judgment, and manage competing priorities.

• Willingness and ability to travel approximately 40–60% of the time.

• A valid driver’s license is required.

• Fluent in written and verbal English.

• Experience with Phase I–IV clinical trials, Medidata Rave or Oracle InForm, and mentoring junior CRAs is preferred.

🏝️ Benefits

• 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 to 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.