Skip to main content

This job has expired

Site Activation and Regulatory Assistant

Employer
Worldwide Clinical Trials
Location
Belgrade, RS
Salary
Competitive
Start date
24 Nov 2020
Closing date
11 Dec 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Send job

Job Details

The Site Activation and Regulatory Operations Assistant provides general and project specific administrative support to Regulatory Affairs, Site Contracts and Site Activation groups.

RESPONSIBILITIES:

  • If applicable, under the direction of a senior member of the department, coordinate & manage compilation of regulatory & ethics committee submissions throughout EU, CIS, Asia Pacific and Latin America regions
  • Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels
  • Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools
  • Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting
  • Liaise with Finance requesting fee payment to Regulatory Authorities
  • Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action
  • If applicable, contribute as owner of Country Intelligence Pages
  • Coordinate Contracts signatures by Worldwide authorized personnel, where applicable
  • Ensure department specific study files are submitted to Central Records and are consistently audit ready
  • Manage tracking of original site contracts delivery to Worldwide Central Archive and/or Sponsor
  • Prepare and submits hardcopies or electronic copies of site essential documents for storage at Central Records
  • Support Business Development activities by archiving emails and assisting with generation of slides
  • Provide relevant administrative training and support to junior staff
  • Provide admin support to Country Intelligence pages and database, Feasibility activities
  • Manage third party vendors such as printing, courier and translation service providers
  • Provide general administrative assistance for the smooth running of the department - organize meetings and record minutes, manage diaries, assist with process improvement initiatives
  • May administratively support therapeutic area specific training activities in coordination with SAR department Training Lead if needed or for professional self-development if desired.


OTHER SKILLS AND ABILITIES:
  • Clearly, proven organizational and time management skills are essential attributes
  • Excellent written and verbal communication skills to clearly and concisely present information
  • Good interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Excellent ability to handle multiple tasks
  • Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
  • Excellent self-motivation skills
  • Willingness to adapt to new procedural requirements
  • Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

REQUIREMENTS:
  • 2 years office/business experience in a supporting role
  • Preferable CRO/pharmaceutical industry experience.
  • Bachelor's degree or equivalent preferred

    #LI-KP1

Company

Find out more about working for our company

Worldwide Clinical Trials -hub-button

Brief Company Description; 

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

 

Company info
Website
Mini-site
Worldwide Clinical Trials
Telephone
+44 115 956 7711
Location
1st Floor Waterfront House
Beeston Business Park
Beeston
Nottingham
Nottinghamshire
NG9 1LA
United Kingdom
Send job

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert