Senior Clinical Research Associate Role in Clinical Trials

Clinical Research Associate Senior Role

As a senior clinical research associate, you will be responsible for ensuring the performance and compliance of assigned protocols and sites in a country. You will work under the oversight of the CRA manager to ensure compliance with ICH/GCP and country regulations, our company policies and procedures, quality standards, and adverse event reporting requirements internally and externally.

You will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. Your role will also involve actively developing and expanding the territory for clinical research, finding and developing new sites.

Key Responsibilities:

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• Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.">
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.">
• Gain an in-depth understanding of the study protocol and related procedures.">
• Coordinate & manage various tasks in collaboration with other sponsor roles to achieve Site Ready.">
• Participate & provide inputs on site selection and validation activities.">
• Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate, and unbiased.">
• Conduct site visits including, but not limited to, validation visits, initiation visits, monitoring visits, close-out visits, and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner.">
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.">
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.">
• Identify, assess, and resolve site performance, quality, or compliance problems and escalate per defined CRA Escalation Pathway as appropriate in collaboration with CRA manager, CRM, and RCPM.">
• Manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate and per timelines.">
• Contribute to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor, and sharing best practices as appropriate/required.">
• Support and/or lead audit/inspection activities as needed.">
• Following the country strategy defined by CRD and CRA manager, contribute to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.">

Requirements:

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• Experience in direct site management (monitoring) and experience in a bio/pharma/CRO.">
• Previous experience in Oncology clinical research studies.">
• Fluent in Portuguese and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.">
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law & guidelines.">
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.">
• Hands-on knowledge of Good Documentation Practices.">
• Proven Skills in Site Management, including management of site performance and patient recruitment.">
• Demonstrated high level of monitoring skill within independent professional judgment.">
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet, and mobile devices) and ability to adapt to new IT applications on various devices.">
• Ability to understand and analyze data/metrics and act appropriately.">
• Effective time management, organizational, and interpersonal skills, conflict management, problem-solving skills.">
• Able to work highly independently across multiple protocols, sites, and therapy areas.">
• High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.">
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.">
• Demonstrates commitment to Customer focus.">
• Works with high quality and compliance mind-set.">
• Ability to travel domestically and internationally approximately 65%-75% of working time.">
• Expected traveling 2-3 days/week.">

Benefits:

This is a pipeline advertisement for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement, you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

Work Experience:

We seek candidates who have hands-on experience in direct site management (monitoring), preferably in a bio/pharma/CRO setting. Previous experience in Oncology clinical research studies would be beneficial.

Education:

Preferred qualifications include a B.A./B.S. with a strong emphasis in science and/or biology.