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Job Description Summary
The Study Start Up (SSU) Associate function is to support the SSU Manager with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements.
Job Description
THE STUDY START UP ASSOCIATE ROLE
The Study Start Up (SSU) Associate function is to support the SSU Manager with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements.
KEY RESPONSABILITIES
Coordinates and assists with all start up activities prior to site activation, including but not limited to:
- Submission of required documents to ethic committees, regulatory authorities, sites and sponsor.
- Submission of the clinical study agreement for review, as needed.
- Contribution to/coordination of site Informed Consent Form (ICF) localization and guidance in line with regulatory / health authority requirements.
- Contribution to localize global Informed Consent Form (ICF) with country requirements.
- Understanding and dissemination of information related to Ethics Committee, meeting dates & costs to relevant stakeholders.
- Understanding and dissemination of information related to Ethics applications & associated online systems.
- Clinical Trial Health Authority application and regulatory submission process.
- Supporting with the Contracts & Indemnity request process.
- Collation/provision of other materials and documentation used by the study requiring local governance approval.
- Maintain up to date knowledge, ensuring study adherence and compliance with local regulatory requirements and associated documentation in line with SSU Manager oversight/input.
- Contribute to collation of metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contract negotiation.
- Ensure all start up information & requirements are kept up to date in a central repository for project teams.
- Track metrics and study start-up timelines to identify trends and opportunities for improvement.
- Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities.
- Assist with identification and tracking of new sites in collaboration with CRAs.
DESIRED QUALIFICATION & EXPERIENCE
- University Degree or equivalent preferably in a medical/science-related field.
- Prior work experience demonstrating knowledge and understanding of clinical trials.
- Demonstrated knowledge and understanding of ICH-GCP and a desire to increase specialist knowledge in regulatory, ethics and contractual requirements for SSU in clinical trials for European and international trials.
TECHNICAL COMPETENCES & SOFT SKILLS
- Good communications skills including the ability to: ask questions, seek clarification, communicate facts objectively, challenge when appropriate, and pursue issues to resolution.
- Ability to present clear messages from complex information/data to all levels in the organization in both written and spoken English.​
- Experience in working as part of a team with a proven ability to make an active contribution to the team's performance and teamwork.
- Self-motivated, assertive, and displays initiative.
- Proven organizational skills and the ability to prioritize and manage multiple tasks with flexibility.
- Demonstrated computer literacy, usage of MS Office software, web-based systems and databases.
- Availability to travel domestically and internationally if required.
WORKING CONDITIONS/PHYSICAL DEMANDS
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.
Languages
English
Education
Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Medicine
Contract Type
Regular
