Clinical Trial Support Specialist / Senior Clinical Trial Support Specialist - US
- Expired: November 27, 2021. Applications are no longer accepted.
Work as part of the Clinical Study Team, to conduct and facilitate the smooth running of Adaptimmune clinical trials from study start up through to study close out, in accordance with relevant regulations, SOPs, and study specific procedures.
The Clinical Trial Support Specialist will be responsible for assisting the Clinical Scientist with the day-to-day coordination and administration activities required in the running of Adaptimmune clinical trials.
Clinical Trial Support Specialist activities will include but are not limited to preparation of site submission start up packages, interaction with sites to ensure all required documents are in place for site activation, filing of study documents in the study Trial Master File and coordinate and prepare study documentation including ICFs, Study Manuals etc.
Senior CTSS will provide support for other activities such as taking part in site qualification, initiation and monitoring visits. This includes successfully building strong external relationships.
The Senior CTSS will assist with the writing of clinical documents such as IBs, protocols and clinical study reports.
Senior CTSS may be required to provide additional support to the clinical team, this support can include activities such as contributing to SOP development, initiate process improvement and/or provide mentorship to other team members.
In addition, the Senior CTSS role will involve problem solving and finding innovative solutions or taking a new perspective on things to create a positive outcome. They will also be responsible for leading on designated projects or project steps and will have accountability for certain milestones in relation to those projects.
Study Start up
- Support EU/US site pre-qualification
- Assign site and PI numbers
- Review and validate site identification list
- Follow up with site on ethics submission and approval received (initial submission and amendments)
- Review feedback/comments from sites on the ICF to ensure compliance with ADAP requirements; resolve changes requested by the site and approve with support from Clinical Team, safety and legal.
- Prepare, collect, and negotiate Confidentially Agreements (CDA) as required. Resolve CSA changes requested by the site and approve any change in CSA language with support from Clinical Team and Legal; Collect internal CSA signatures
- Interface with internal TMF group to ensure site submission package is sent and start up documents are submitted to TMF
- Work with Contract Research Organisation (CRO) to ensure study start up activities are completed within agreed timelines
- Support Clinical Team with the organisation and conduct of Site Qualification and Site Initiation visits
- Support with the drafting and review coordination of clinical documents required for study start up (i.e. Protocol, IB, ICFs and study manuals)
- Manage SAE email distribution
- Ensure good understanding of project scope, milestones, budgets to confirm payment of invoices
- Submit relevant documents to the Trial Master File
- Create and maintain Study Procedures Manual and ICF as needed
- General Clinical Operations Support
- Liaise with other internal departments to avoid duplication of effort across studies around completion of forms (eg, IBC forms), vendor form updates, etc.
- Manage the SNAP (subject number assignment program) across studies; Maintain relevant SOP
- Proactively keep clinical scientists and manager informed about work progress and any issues (including conflicting priorities and free capacity)
- Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Adaptimmune SOPs, other Adaptimmune training requirements, and study specific procedures and training
- Escalate any issues that require immediate action to the clinical scientist
- Proactively work with team members to meet project goals
- Support metric tracking and protocol deviation quarterly review
- Work with CROs and vendors to ensure the smooth operation of ongoing study activities
- Support Clinical Team with the organisation and conduct of Site Monitoring visits
- Support with the drafting and review coordination of clinical documents revisions (i.e. Protocol, IB, ICFs and study manuals)
- Support Clinical Team with the organisation of study and site wide meetings. Where required present and lead these meetings.
Other Operational Aspects
- Support review and creation of clinical SOPs as required
- Proactively review current clinical processes and implement process improvement with assistance from Clinical Team
- Provide mentorship to CTSS/Junior CTSS
Qualifications & Experience
- Bachelors degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
Skills & Compentencies
- Client focused approach to work
- Ability to manage multiple and varied tasks with enthusiasm
- Attention to detail
- Strong interpersonal, verbal, and written communication skills
- Sense of urgency and follow through in completing assigned tasks
- Effective time management in order to meet daily metrics, team objectives, and department goals
- Good presentation skills
- Excellent communication skills
- Inspire others
- Change management skills
- Relationship building skills
- Ability to problem solve
- Critical thinking
decision making authority
- Although good judgement when encountering issues is required for this position, the ultimate decision for action will be made at a higher level. The Senior CTSS should escalate to Head of Site and Vendor Management or Clinical Scientist.
- Valid driver's license
- Fluent in local office language and in English, both written and verbal
- Ability to travel internationally (valid passport).
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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