CRA II/Senior CRA

Job Opportunity: Senior Clinical Research Associate 

Are you passionate about advancing healthcare and making a difference in the world?
Join our dynamic team as a Senior Clinical Research Associate (SCRA), where you will play a pivotal role in guiding small to medium biopharmaceutical companies through the intricate landscape of clinical trials, ultimately bringing life-changing therapies to patients globally.

Location: Hybrid/Remote*

As a SCRA, you will independently manage and monitor investigation sites, proactively identify and resolve issues, and ensure clinical studies are conducted according to protocols and compliance standards. You will be the essential link between project teams and site staff, ensuring the smooth and efficient conduct of clinical trials.

Key Responsibilities:

• Govern quality standards for trial monitoring activities.
• Conduct Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites as per project schedule.
• Monitor clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols.
• Track and supervise the collection of ongoing study data for regular project status reporting.
• Collect and review regulatory documents as required.
• Prepare site visit and telephone contact reports.
• Maintain and update CTMS in compliance with SOPs and study-specific directives.
• Act as Document Owner for collected documents.
• Participate in study start-up processes, including preparing Informed Consent forms, developing study documents, and managing site contracts.
• Resolve site issues and ensure smooth communication between the project team and site staff.
• Collaborate with the Centralized Monitoring Team to evaluate risk-based monitoring activities.
• Identify and address logistical and practical problems, supporting the project team in creating solutions and contingency plans.
• Ensure continuous maintenance of the Trial Master File and Investigator Site File.
• Assist the Project Manager and Clinical Team Leader in generating study-specific forms and following up for timely completion and submission.
• Support the start-up team or sponsor in obtaining authorization of regulatory documents and site contracts.
• Attend and organize Investigator Meetings and study-specific training sessions.
• Participate in feasibility and site identification activities as needed.
• Prepare and attend Assessment Visits with senior CRA, CTL, or Clinical Research Manager.
• Process interim and final payments to Investigators.
• Provide in-house review of CRFs and support site staff in preparing for audits and inspections.
• Report quality issues and support root cause analysis and corrective actions.
• Contribute to country-specific, GCO, and CTO initiatives for improvements and quality enhancement.
• Manage multiple projects and tasks independently and as part of a team.

Requirements:

• At least three years of clinical monitoring or relevant clinical trial experience.
• Relevant life science degree, healthcare, nursing background, or related degree.
• Strong knowledge of medical terminology and clinical monitoring processes.
• Excellent communication skills in both Local and English languages, written and verbal.
• Strong interpersonal and organizational skills.
• Ability to translate guidelines, rules, and regulations into clear recommendations.
• Client-focused, representative, and outgoing personality.
• Ability to thrive in a fast-paced and challenging environment.
• In-depth therapeutic and protocol knowledge.
• Willingness to travel up to 8 days per month, depending on project needs.
• Proficiency with computer applications such as Word, Excel, and PowerPoint.
• Demonstrated ability to manage multiple projects and mentor colleagues.
• Attention to detail and administrative excellence.

Benefits:

• Comprehensive benefits package.
• Competitive salaries.
• Departmental Study/Training Budget for professional development.
• Flexible working hours.
• Opportunity for remote/hybrid* work.
• Leadership and mentoring opportunities.
• Participation in our Buddy Program.
• Internal growth and career progression opportunities.
• Financially rewarding employee referral program.
• Access to online training via GoodHabitz and internal platforms.
• Eligibility for Spot Bonus and Loyalty Award Programs.

*Our hybrid work policy encourages a dynamic work environment, requiring 2 days in the office per week for employees within reasonable distance from one of our locations.

Join Us and Make a Difference!

If you are ready to contribute to ground-breaking clinical research and be part of an inspiring team, apply now to become a part of the team.
Let's bring life-changing therapies to those who need them most!