Sr/Site Start Up Associate II

What you'll be doing:

• Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level.

• Prepares ongoing submissions, amendments, and periodic notifications (including safety reporting) required by central and local EC and RA, and other local regulatory authorities as needed within the country, as required by local rules. Submits end of study notifications to RA, ECs/IRBs and other local authorities in the specified country according to national timelines.

• Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.

• Local Investigator Contract and Budget Negotiator (where applicable) - produces site-specific contracts from country template.  Submit proposed contract and budget to the site for review.  Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.

• Conducts the site identification process by contacting sites to confirm the investigator’s interest and eligibility to participate in a clinical trial protocol. Liaises with the Site Identification Lead to assist Medical Informatics team with site outreach for pre-award assessments as needed.

• Prepares Investigational Product (IP) checklist according to country regulations.

• Ensures accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.

• Provides all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct.

• Collects information on submission deadlines and timeline metrics for RAs, ECs, IRBs 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. RA, ECs/IRB 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 guidance on data protection compliance at a country level for data protection statements that need to be included on documents which the Sponsor has contracted to the Company start-up group; this typically includes the Principal Investigator/Informed Consent and the CDA/contract template.

• Sets up and maintains a folder with country ECs/IRBs and local authority addresses and requirements, as required.

• The SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the Global Study Start-Up portal on SharePoint.

• Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.

• Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.

• May provide regular updates of country specific information on the Global Study Start-Up portal on SharePoint.

• Enters and maintains trial status information relating to SSU activities into Premier’s tracking databases, in an accurate and timely manner.

• Ensures documentation of QC of eTMF within the scope of File Management Plan (FMP) 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 employees and other applicable internal teams for changes in country specific regulations for clinical trials.

• Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.

• Serves as primary liaison for site start-up and site start-up management issues, escalating to RSM, CL and/or PM as required.

• Ensures that all site start-up tasks meet expectations and are delivered in accordance with the contracted timelines.

• Interacts with site, clients, vendors and other functional areas as secondary project contact for site issues and questions.

What we're looking for:

• Undergraduate degree or its international equivalent in a clinical, science, or health related field from an accredited institution or a licensed healthcare professional.

• Proven experience as a SSUA I and/or 5+ years of related experience, including at least 3 years of experience in the submission of clinical trial applications.

• Experience working on different study types/phases such as interventional IMP studies, non-interventional studies, Medical Device studies, GMO studies, and observational studies.

• Working knowledge of FDA Guidance Documents / EU Directives/Regulations / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures.

• Expertise in ICH/GCP and/or ISO14155 requirements and local regulatory authority drug research and development regulations.

• Detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials and of site and institution specific contract requirements

• Detailed 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.

• Proficient in the development and review of Informed Consent Form templates, other patient documents, or specific documentation that is required in the country.

• Ability to read, write, and speak fluent English and fluent in host country language.

• Ability to manage several tasks and work effectively in a fast-paced environment with changing priorities.

• Ability to work independently with minimal supervision and complete work accurately, within quality expectations and agreed timelines.

• Ability to interpret directives and guidelines.