The Role
Support SSU Manager with clinical trial start-up activities: prepare and submit regulatory/ethics documents, localize ICFs, track timelines and metrics, maintain central study repositories, coordinate with sites, ECs and sponsors, and assist site identification and contract/indemnity processes.
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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 ROLEThe 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
EnglishEducation
Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): MedicineContract Type
RegularSkills Required
- Bachelor's degree in Life Sciences or Medicine
- Prior work experience demonstrating knowledge and understanding of clinical trials
- Demonstrated knowledge and understanding of ICH-GCP
- Experience submitting documents to ethics committees, regulatory authorities, sites and sponsors
- Experience with clinical trial regulatory submission processes and health authority applications
- Experience coordinating Informed Consent Form (ICF) localization and country-specific requirements
- Proven organizational skills and ability to prioritize and manage multiple tasks
- Good written and spoken English communication skills
- Experience working in teams and contributing to team performance
- Self-motivated, assertive, and displays initiative
- Demonstrated computer literacy including MS Office, web-based systems and databases
- Availability to travel domestically and internationally if required
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The Company
