DOCS Global

Clinical Project Associate / Immediate Start!!! / Hampshire UK

Eastleigh Southampton Hampshire, UK
15 Apr 2021
15 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Key Responsibilities include:
• Supporting the management and oversight of global clinical trials
• Essential document management
• Maintaining study level storyboard for critical timeline oversight
• Compiling IRB/EC submission documentation
• To coordinate, author and manage preparation of clinical trial documentation and training materials (including investigator meetings, site evaluation and initiation training)
• Facilitate development of Investigational Product Information Manual and study specific Important Protocol Deviation list
• Managing processes for planning, procuring and oversight of ancillary clinical supplies
• Creation and management of study specific tools, including:
o Global/country level recruitment and retention materials
o Authoring and distribution of study newsletters
• Vendor management (including set up, tracking and issue resolution over the life of the study)
• Tracking and collation of study data and metrics utilizing multiple clinical systems
• Preparing clinical study team meeting agendas and minutes, facilitating cross-functional meetings
• Managing global versioning and distribution of documents (e.g. informed consent forms)

Critical Success Factors for the Role include:
• In depth knowledge of drug development processes
• Experience or familiarity with advanced concepts of clinical research
• Demonstrated experience gained within a clinical research environment on clinical studies
• Extensive knowledge of technical, scientific and medical terms
• Advanced Microsoft Office skills. Demonstrable understanding of pivot tables and use of advanced Excel formulae would be a distinct advantage.
• Detailed knowledge of Good Clinical Practice (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scientific and clinical terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Excellent communication skills
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment
• Proactivity

What is required
• Ideally a minimum of 2/3 years' experience gained within the clinical research industry on commercial clinical studies within a CRO, pharmaceutical or biotech working environment
• CRA/clinical trial monitoring experience preferred
• Proactive, flexible and problem-solving work approach with strong policy, process and procedural conformance
• BA/BS/BSc in life sciences or RN
• Full-time availability
• Full and valid UK working eligibility

What is offered
• Permanent full time contract of employment with DOCS seconded to the client
• Structured 4-week training for all new starters
• Office-based in Eastleigh /Hampshire 3 days per week with 2 days home-working per week.
• Salary depending on level of skills and experience plus company benefits (23 days annual leave, pension, healthcare cover, etc.)

Why Join DOCS?
We are a successful company offering great and rewarding career scope. To express your interest please send your CV today to or ring +33 964 25 67 65.

*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.