Senior Clinical Research Associate (Medical Device)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON is searching for Sr. CRAs with Medical Device experience to be home-based in the United States. This position will travel nationwide to sites less than 30% of the time. The remaining time is spent in home-office. ICON is looking for Sr. CRAs with at least 6 years of monitoring experience. Medical Device experience is preferred by not required.


This position monitors progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements. Provides support in start-up, enrollment, follow up and closure of clinical trial activities.

Responsibilities:

•Source verification: Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records. Issue, investigate and resolve data discrepancies.
•Communications: Ensures clear written communication to clinical sites and project team members through monitoring reports, follow up letters, study memos, and general correspondence. Thorough documentation and proper escalation of issues is essential in all visit reports.
•Training: Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitor and maintain site personnel list, qualification and training records.
•Site compliance: Ensures any identified non-compliance issues are addressed, clearly communicated, documented and escalated as requires through monitoring visits, analyzing study metrics, and general study data overview. Support regulatory inspection activities as required.
•Event reporting: Ensures that all reportable events are identified, clearly documented and reported per protocol and as per applicable requirements and regulations.
•Collaboration: Participates in study specific meetings, teleconferences and trainings. Collaborates with cross functional team members and study sites throughout all study phases.
•Documentation: Manages study contracts, request/collection of relevant site documentation, review and approval of subset of documents in applicable database. Performs budget negotiations.

Qualifications:

•BS/BA required
•Ability to travel approximately 30% of the time nationwide
•Ability to independently oversee sites and handle not only monitoring responsibility but also oversee site management activities

Benefits of Working in ICON:

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.

At 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.

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, color, 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.

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