Clinical Trial Associate
Location: Belgrade, Central Serbia, Serbia
Requisition Number: 1574
Position Title: Clinical Trials Associate
SUMMARY: The Clinical Trials Associate is a full-time position responsible for ensuring all assigned projects for Project Management are performed timely and accurately while interfacing directly with in-house personnel and field employees. The Clinical Trials Associate reports directly to the Associate Director of Project Management. Required tools, forms and documents, and provides additional administrative support for Project Management and Clinical Operations.
Tasks may include but are not limited to:
- Develop and maintain documents, tools, forms and related items in MS Word, Excel, Access and Publisher, including reformatting and troubleshooting issues with existing documents and macros
- Assistance to Project Managers and their projects
- Assists in the development of project timelines and milestone tracking
- Provide technical assistance to project team (Project Managers, Lead CRAs, CRAs, etc.) with forms, letters, reports, manuals and other documents
- Manage document control functions, including maintaining Master List of paper and electronic documents and media generated and distributed
- Maintains an overall project team calendar
- Participates and assists in the planning and implementation of client and/or investigator meetings along with any other related meetings
- Audit and resolve issues of redundancy, currency and consistency of documents on shared drive and portals
- Maintain and quality audit to assure most recent revisions of documents are on portals and server
- Track and maintain Clinical Research Associate (CRA) site visits calendars, Transmittal Logs, Training Logs and Contact Lists as appropriate
- Develop and distribute periodic communications, such as newsletter
- Assist project team (CRAs, Lead CRAs and Project Managers, e) with collation of documentation required for submission to Regulatory Authorities and Ethics Committees administrative support to the preparation of contracts
- Assist with maintenance of trial master file documents as appropriate and needed
- In liaison with the CRAs, manage preparation of documents for grant payments
- Regularly review the status of key documentation in the file for SOP compliance
- Interviews, trains, and develops new employees as needed
- Provide training to new staff on administrative procedures and tools
- Coordinate and direct administrative support functions
- Provide support to Clinical Operations Manager on an ad hoc b
- Assists Project Management staff with defining expectations and performance levels of other CTA staff members
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
- Excellent written and verbal communication skills
- Ability to work independently and as a team member
- Strong interpersonal skills in a fast-paced and rapidly changing environment
- Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
- Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
- Strong organizational skills, including ability to develop naming conventions and filing architecture
- Advanced skills in MS Office applications including Microsoft Word, Access, Excel, PowerPoint and Publisher.
- Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
- Excellent spoken and written English skills as well as fluency of the language of the country of location
Required: Two year college curriculum and one or more years’ experience in office administration or similar position
Preferred: Four year college curriculum or university degree OR similar education in business administration and /or medical fields.
Other: The Senior Clinical Trials Associate has a large amount of contact with clients and staff. Professionalism will be of the utmost importance as a representative of WCT.
Employment Type: Regular
Community / Marketing Title: Clinical Trial Associate
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Belgrade, RS