Senior CRA

Lead the oversight that keeps clinical trials on track, compliant, and delivered with excellence.

The Senior Clinical Research Associate (Sr CRA) is a key member of the clinical team, responsible for conducting site monitoring activities and providing leadership, oversight, and guidance in the management and execution of clinical trials. The Sr CRA ensures compliance with protocols, timelines, and quality standards while working closely with cross‑functional teams to address site‑related issues, support recruitment, and ensure protocol adherence.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

• Provide guidance and oversight to the CRA team, ensuring adherence to project scope, SOPs, timelines, and budgets.
• Conduct co‑monitoring and evaluation visits as needed, reviewing monitoring visit reports.
• Ensure timely and appropriate investigator site visits.
• Collaborate with cross‑functional departments to resolve clinical trial monitoring issues.
• Assist in developing study‑specific Monitoring Plans and training materials.
• Support site‑specific ethics document collection and site contract negotiations.
• Manage study budgets and act as a sponsor referent for monitoring stand‑alone projects.
• Perform qualification, initiation, interim, and close‑out visits both remotely and onsite.
• Document monitoring visits, ensuring proper resolution of site‑related problems and protocol deviations.
• Verify CRF data integrity through meticulous source document review.
• Conduct investigational product accountability and ensure regulatory binder compliance.
• Maintain regular contact with study sites to ensure protocol and GCP compliance.
• Facilitate adverse event reporting and SAE reconciliation.
• Resolve data discrepancies in collaboration with in‑house CRAs and data management.
• Identify and address site issues proactively, developing problem‑solving strategies.
• Mentor new CRAs and assist in onboarding.
• Participate in internal, client, and sponsor meetings as required.
• Support audit preparation at study sites and contribute to CTMS development and maintenance.

Key Skills and Requirements

• Bachelor's degree in life sciences or related discipline preferred.
• Minimum of 3 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry.
• Proven ability to autonomously manage monitoring activities.
• Quality‑focused with strong attention to detail.
• Excellent organizational and multitasking skills in a fast‑paced environment.
• Strong analytical, negotiation, and leadership abilities.
• Ability to travel and manage stress effectively.
• Professional, trustworthy, and disciplined.
• Proficient in English (written and verbal) and local language where monitoring activities are performed.
• Strong interpersonal and communication skills with a customer service orientation.
• Proficient in clinical trial management systems, databases, and electronic data capture tools.
• Knowledge of clinical research, ICH GCP, local regulations, and ethical requirements.
• Self‑starter who thrives in a collaborative yet dynamic environment.