CRA II - SCRA, CNS
- Contract Type
- The Clinical Research Associate will complete project activities associated with monitoring functions of Phase I-IV clinical research studies whilst developing mastery and a thorough understanding of the drug development process.
- Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- May assume clinical functional leadership tasks as assigned, acting as Lead CRA for a study.
The ideal candidate will need the following experience / skills to be considered:
- BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience.
- Extensive experience as a CRA with a thorough understanding of SOPs, WIs, FDA and local regulations as well as ICH-GCP guidelines.
- On site experience: signed off on all types of visits; PSSV, SIV, IMV, COV.
- Comfortable in navigation within, and able to assist junior staff in: CTMS systems, Data Platforms for assigned projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems.
We have a comprehensive benefits package and offer highly competitive remuneration.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
If you have the required experience for this position and are eligible to work in the required location then please apply.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
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.