Clinical Trial Associate

Jobtailor; Cambridge; On-site; GBP 28,000 - 42,000; Full time

Job summary

Jobtailor, Cambridge-based clinical research support, seeks a coordinator to manage study start-up activities, liaise with sites, and ensure regulatory submissions. You will prepare and maintain SIP documents, track feasibility questionnaires, and support data management in eClinical.

The role requires experience in NHS or clinical research setting, strong MS Office skills, and ability to work with multiple electronic systems in a fast-paced environment.

Qualifications

• BA/BS/BSc or qualified nurse.
• UK-based clinical trial coordination/administration experience.
• Proven MS Office and EDC systems proficiency.
• Ability to work in fast-paced environments with multiple electronic systems.
• Valid, current UK working eligibility.
• Start immediately or within 1 month.

Responsibilities

• Responsible for study start-up activities: create site folders, prepare SIP documents, update systems.
• Liaise with clinical sites to collect, review and track feasibility questionnaires.
• Coordinate entry and maintenance of local data in study management systems, incl. setting up new studies in eClinical.
• Ensure collection, review, tracking and provision of regulatory/IRB/IEC submissions documents.
• Track and maintain study supplies; distribute to sites.
• Organise Investigator meetings and monitor workshops; participate as needed.
• Process and submit essential documents to RIM/EPIC or local archive.
• Manage Case Report Forms; follow up on queries.

Skills

Clinical Trial Coordination

Regulatory Submissions

Data Management

MS Office Proficiency

EClinical Systems

Education

BA/BS/BSc

Qualified Nurse

Tools

EDC Systems

Study Management Systems

Job description

• 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