Clinical Research Associate II (CRA II) - Part-Time
SSU - Submission Experience is required
Come discover what our 25,000+ employees already know : work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason we improve patients’ lives around the world.
Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
immediately communicates / escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
Demonstrates diligence in protecting the confidentiality of each subject / patient. Assesses factors that might affect subject / patient’s safety and clinical data integrity at an investigator / physician site such as protocol deviation / violations and pharmacovigilance issues.
o Assesses site processes
o Conducts Source Document Review of appropriate site source documents and medical records
o Verifies required clinical data entered in the case report form (CRF) is accurate and complete
o Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
o Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture
o Verifies site compliance with electronic data capture requirements
Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.
Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Supports subject / patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Must be able to quickly adapt to changing priorities to achieve goals / targets.
completes assigned training as required.
o Site support throughout the study lifecycle from site identification through close-out
o Knowledge of local requirements for real world late phase study designs
o Chart abstraction activities and data collection
o Collaboration with Sponsor affiliates, medical science liaisons and local country staff
o The SMA II may be requested to train junior staff
o Identify and communicate out of scope activities to Lead CRA / Project Manager
o Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
What we’re looking for
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.
Learn more about Syneos Health.
Additional Information :
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Europe - ROU-Bucharest-Tudor-Arghezi-St