Clinical Research Associate II - East Coast

As a Clinical Research Associate, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The primary responsibilities of this position include assessing qualifications of potential clinical study sites, implementing clinical studies at participating sites, managing the conduct of clinical studies at sites, ensuring the quality of site performance, and closing clinical studies.

This individual will ensure that clinical trials are conducted according to the approved protocol/protocol amendments and complies with Good Clinical Practice (GCP), Company SOPs and all applicable regulatory requirements.

• Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.
• Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
• Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
• Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
• Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
• Ensures subjects’ rights, safety and well-being are protected.
• Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
• Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
• Assists and supports data validation and data cleaning procedures to ensure timelines are met.
• Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate
• intervention plan for the avoidance of redundant errors and deviations.
• Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
• Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
• Ensures availability of non-clinical materials for sites.
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Gains an in-depth understanding of study protocols and related procedures.

Qualifications Needed:

• Position requires BA/BS , preferably in the Life Sciences, or RN
• Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock.
• Strong Oncology monitoring experience in phase 1-3 pharmaceutical/ biotechnology clinical trials
• Possess good understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
• Good knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems
• Proficiency in the use of the Microsoft Office
• Ability to handle and prioritize multiple studies and projects. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Works with high quality and compliance mindset
• Possess a valid driver’s license
• Must be willing to travel and spend 8-10 days /month on site.

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.