Senior Clinical Research Associate, Romania

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

📋 Description

• Independently carry out, coordinate, and oversee clinical site monitoring activities.

• Evaluate protocol adherence and regulatory compliance in line with established procedures, ICH/GCP guidelines, and local regulations.

• Act as the primary point of contact between the sponsor/Alimentiv and investigative sites.

• Implement clinical study plans effectively.

• Offer guidance and mentorship to CRA I and II team members.

• Conduct and document onsite and remote monitoring, close-out, qualification, and initiation visits.

• Review study data against original documents and address or escalate data inquiries.

• Organize the shipment and delivery of clinical supplies and study materials.

• Educate site personnel on protocols, study plans, systems, and ICH-GCP standards.

• Oversee site activation, recruitment milestones, site-related issues, action items, and protocol deviations.

• Examine ISF, TMF, and study systems for accuracy, timeliness, and completeness.

• Participate in investigator meetings, study meetings, audits, and inspections.

• Conduct CRA Assessment Visits and co-monitoring visits.

• Assist in hiring interviews, process enhancements, and the development of best practices.

⛳️ Requirements

• 4 - 6 years of relevant experience.

• Bachelor’s degree (Honors preferred).

• Proficient in both written and spoken English.

• Alternatively, a combination of education and experience may be considered.

• In-depth knowledge of ICH-GCP and local regulatory standards.

• Skilled in EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.

• Willingness to travel up to 40-60%, depending on project requirements and site locations.

• Strong interpersonal and problem-solving abilities; able to work autonomously and within cross-functional teams.

• Excellent communication and organizational skills, with a keen attention to detail and a sense of urgency.

• Possession of a valid driver’s license.

• Preferred degrees include Health Sciences, Life Sciences, Pharmacy, or Nursing, along with Sr.CRA and/or ACRP Certification/Designation.

• Experience with Phase I–IV clinical trials is preferred.

🏝️ Benefits

• 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 cover business-related communication expenses (internet, VoIP, landline, etc.).

• Monthly cell phone allowance of 50 RON.

• One-time expense reimbursement of up to 500.00 (local currency) for purchasing office equipment such as a scanner/printer, additional monitor, office furniture, and supplies.

• Mileage reimbursement for travel-related expenses.

• Flexible home-based work arrangement.