Site Start Up & Regulatory Specialist II

Recruiter
Syneos Health
Location
All Cannings
Posted
12 Oct 2018
Closes
15 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
At Syneos Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment.

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

A brief summary of duties you will be involved in as a Site Start up Specialist:

- Reviewing essential document packages for site activation
- Preparation and submitting of Central EC Applications, Local EC Applications, - RA Applications, and other local regulatory authorities or hospital approval submissions as required
- Reviewing Informed Consent Forms
- Negotiating terms and budget of the contract with Investigator Sites

Qualifications



To succeed in this role you will need the following skills/experience:

- Previous experience in clinical research including submissions experience and site contract negotiation
- Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.

If you are interested to find out more please reach out to me on leah.morgan@syneoshealth.com or apply directly online.



Disclaimer:



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. #LI-LM1

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