- Responsible for study start-up activities, including creating site folders, collating, preparing and maintaining (e) SIP documents, and updating systems
- Liaise with clinical sites to collect, review and track feasibility questionnaires
- Coordinate entry and maintenance of local data in study management systems, including setting up new studies in eClinical
- Ensure collection, review, tracking and provision of clinical documents for regulatory and IRB/IEC submissions
- Track and maintain study-related supplies and facilitate distribution to sites
- Organise and participate in Investigator meetings and monitor workshops
- Process, reconcile, distribute and track essential documents and submit them to RIM/EPIC or local archive
- Order, process and track Case Report Forms and follow up on query resolution
- Manage local distribution of Investigator Brochure
- Prepare and review site communication documents and facilitate mass mailings/faxes
- Provide administrative support including word processing, photocopying, faxing, filing, correspondence, presentations and basic software support
- Interact with the Clinical Research Services Manager on project or study-related work
- Support execution of clinical studies and contribute to department goals and continuous improvement
Requirements
- Ideally BA/BS/BSc or qualified nurse
- UK-based clinical trial co-ordination/administration experience gained within the clinical research industry or within NHS trust/hospital setting
- Proven ability to work efficiently and accurately with MS Office and EDC systems
- Ability to work effectively within a fast-paced working environment using different electronic systems
- Excellent and accurate attention to detail when entering data onto systems/database
- Valid, current UK working eligibility
- Start immediately or with 1 month notice maximum
Core Competencies
Demonstrates expertise in clinical trial coordination and administration, with a strong focus on study start-up activities, regulatory submissions, and data management. Proficient in utilizing electronic systems and MS Office to support clinical research operations effectively.
Highest-signal resume keywords
- Clinical Trial Coordination
- Regulatory Submissions
- Data Management
- MS Office Proficiency
- EClinical Systems
Hard Skills
- Study Start-Up Activities
- Feasibility Questionnaire Tracking
- Clinical Document Review
- Case Report Form Processing
- Investigator Brochure Management
Soft Skills
- Attention to Detail
- Organizational Skills
- Effective Communication
Certifications & Qualifications
- BA/BS/BSc
- Qualified Nurse
Industry Keywords
- Clinical Research
- NHS Trust
- IRB/IEC Submissions
- Investigator Meetings
Tools & Technologies
- EDC Systems
- Study Management Systems
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Clinical Trial Associate in Cambridge employer: Jobtailor
As a Client Services Coordinator at our dynamic company, you will thrive in a supportive work culture that prioritises employee growth and development. We offer comprehensive training, opportunities for advancement, and a collaborative environment where your contributions are valued. Located in a vibrant area, our team enjoys a healthy work-life balance and the chance to engage with diverse clients, making every day rewarding and meaningful.
