Clinical Trial Assistant
7 months ago
Company Description
Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.
Our company allows for employee visibility (you have a voice) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
**Job Description**:
A CTA should be able to complete the following tasks as required per their study:
- Carries out assigned administrative duties to support clinical trial conduct
- Setting up Investigator Site File, according to SOPs provided either by the Sponsor or by ERGOMED, and distribute to sites
- Coordinates and attends project meetings (e.g. investigator, kick-off, team, etc.) with the PM/CTM, support preparation of meeting agenda and provides written high quality meeting minutes
- Attends project training sessions according to project and/or Sponsor requirements.
- May assist with TMF set up and maintenance activities as needed under supervision of the Monitor and/or CTM/PM appointed. Works with project teams to assist in tracking, naming and routing of clinical trial documentation to the Trial Master File (TMF), in accordance with the applicable Ergomed PM SOP or Sponsor SOP on Study Document Filing.
- Maintains contact lists, information for project team members (e.g. project training records) and other trackers as required. Provides reports from tracking tools and other ad-hoc reports/trackers as requested.
- If requested by PM/CTM, attends in-house audits and supports completion of Corrective and Preventative Action Plan with respect to all administrative aspects of the project
- Any other task related to the specific clinical trial performance, assigned by ERGOMED Management, either verbally or in writing
**Qualifications**:
- High school diploma or equivalent required, BA/BS degree preferred
- Working knowledge of clinical trials operations preferred
- Administrative work experience, preferably in an international Clinical Research setting
- Ability to plan, multitask and work in a dynamic team environment
- Excellent English oral and written communication skills
- Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project)
Additional Information
Why Ergomed
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
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