Study Start Up Associate (I, II or Sr)
Bring your Passion to Premier!
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Rare Disease and Pediatrics, Analgesia, Neuroscience, Oncology, Dermatology, and Medical Devices.
We're looking for a talented and energetic Site Start Up Associate (I, II or Sr) to join our team in Prague!
Site Start-up Associate provides study start-up metrics and country intelligence information for proposals, provide start-up documents to the Investigator Site File, conducts essential document collection and review, tracking, site communications, Informed Consent review, Ethics Committees submissions and communications, protocol amendment management, submissions and follow-up to the appropriate governing authorities on a per country basis, site contract preparation and follow-up, customs clearance and import/export license management and in general all needed preparations for site activation.
Site Start-Up Associate:
- Takes responsibility for quality deliverables at the country level for site start-up in one or more components.
- Follows project requirements and applicable country rules.
- Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified
- Local Clinical Trial Applications Specialist - may serve as the primary point of contact for the Project Manager, Clinical Lead and Regulatory Start-up Lead (or designee) during start-up on allocated projects.
- Prepares and submits Central EC Applications, Local EC Applications, RA Applications and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. May provide regular updates of country specific information on the clinical trial application database on SharePoint. Submits end of study notifications to Regulatory Authorities, Ethics Committees and other local authorities in the specified country according to national timelines.
- Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
- Prepares checklist for IP release according to country regulations.
- Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.
- Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
- Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees and other local bodies as appropriate.
- Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
- Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Regulatory Authority submissions, Ethics Committees submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/ export license applications where these are obtained with RA applications.
- Provides quality review of the informed consent and adapts the template as appropriate.
- Works within the scope of Regulatory & Start-Up Submission Plan (RSSP), study processes & SOPs, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
- Ensures documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
- May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
- Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
- Reviews and advises on SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.
- Mentors and trains junior level staff.
- 1 – 2 years of related experience (health sciences, biology degree)
- Prior experience using computerized information systems preferred
- Ability to read, write, and speak fluent English; fluent in host country language
- Clinical trials support or pharmaceutical industry experience preferred
- Office based or clinical employment experience preferred
- Knowledge of ICH and local regulatory authority drug research and development regulations preferred
- Successful experience and results at Level 1
- At least 2 years’ experience in the submission of clinical trial applications.
- Expertise in ICH/GCP and/or ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical
- Knowledge of site and institution specific contract requirements
- Clinical trials support or pharmaceutical industry experience required
- Works with internal and external customers/vendors to meet project specific goals
- Identifies, monitors, documents, and tracks out-of-scope activities
- Proficient in the development and review of Informed Consent Form templates
- May serve as an Independent Essential Document Reviewer and/or perform second pass review of Essential Documents
- Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions
- Assists with mentoring and training staff
- Manages time and project requirements based on study contract
- Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent
- Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and
- import/ export license applications where these are obtained with RA applications
- Provides data protection compliance guidance at a country level on data protection statements that need to be included on those documents which the Sponsor
- has contracted to the Company start-up group to adapt to local requirements. This will typically include the Informed Consent and the NDA/Contract template
- Provides input in local SOPs and WG
- Support for the creation of internal training materials on local legislation requirements
- Provides input to the team to assist with EC or CA issue resolution at the country level
- Possible Travel 10%
Level 3 (Senior)
- Same Accountabilities as Level 1 & 2
- 3+ years of related experience
- Serves as primary liaison for country study start-up and site start-up management issues
- Ensures that all site start-up tasks meet expectations and are delivered in accordance within the contracted timelines
- Leads larger programs through start-up
- Possible Travel 10%
EDUCATION, SKILLS & COMPETENCIES:
Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional
Expertise and know-how
- Thorough knowledge of ICH/GCP regulations required
- Working knowledge of FDA Guidance Documents / EU Directives & Regulations / Local Regulations / ISO14155 regulations for drug / device development procedures
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site Start-Up activities will be carried out
Personal skills & behaviors
- Fluent verbal and written English as well as the local language(s) required for clinical trial submissions
- Excellent team player, collaborative and able to build an effective team
- Ability to multitask and work effectively in a fast-paced environment with changing priorities
- Strong verbal and written communication and negotiation skills
- Excellent organizational and time-management skills, able to prioritize work to meet deadlines
- Accountable, dependable and strong commitment
- Is customer-service focused in approach to work, both internally and externally
- Maintains a positive, results orientated work environment