IQVIA Sr. CRA/CRA II, Medical Device (Home-based) - Genae, an IQVIA Business in Indianapolis, Indiana
Seeking a Senior Clinical Research Associate or Clinical Research Associate II with medical device experience!
Objective of the job
To manage, initiate, monitor and close the clinical sites participating in clinical research in compliance with the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and genae SOPs under the supervision of the clinical project manager and/ or sponsor.
To monitor and validate study data, whether on site or in-house according to the applicable SOPs and requirements outlined in the clinical investigational plan (CIP) (if any);
To ensure the participating sites perform clinical research according to the regulatory requirements, timelines, applicable guidelines (ICH-GCP, ISO 14155, FDA 21 CFR) and CIP requirements;
To report on the activities and provide site and patient status information in a timely manner to the Clinical Project Manager;
To attend and contribute to project meetings and trainings as required;
To ensure that project management tracking systems/ databases remain updated;
To act as an intermediary that facilitates a timely and accurate communication flow between the involved parties which may include genae employees, clinical sites, sponsors and third-party vendors;
To pro-actively identify project related issues and discuss strategies with the Clinical Project Manager on how to handle these efficiently;
To represent genae in a professional manner at all times; interfaces with internal and external customer.
Perform miscellaneous job-related duties as assigned
Education: Higher educational degree (BSc, MSc) in a medical or science-related field; pharmacy, nursing or equivalent healthcare professional qualification preferred.
Experience: At least one (1) year of clinical research experience as a Clinical Research Associate, a Data Reviewer or a Study Coordinator or equivalent.
Clear, effective written and verbal communication;
Fluent in English, by preference in more languages;
Pro-active problem solver;
Strong organizational, planning, collaboration and team-building skills;
Ability to work according and towards expected timelines and within budget;
Computer proficiency with Microsoft Office;
Data analysis skills: interpret data and communicate the importance of it, present facts and defend recommendations logically, give context to all corners of the team, be able to set strategies and priorities and address sub-optimal performance.
The working conditions will involve regular up to intensive national and international travelling.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.
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