The Global Study Start-Up Associate manages the coordination, preparation and review of clinical regulatory documents including tracking and reporting of key performance by site and by study. The Global Study Start-Up Associate prepares and/or reviews submissions for clinical studies to local or central IRB/EC and Regulatory Authorities, as appropriate, in an ongoing manner maintaining compliance with local state/province or country laws and regulations. The Global Study Start-Up Associate brings regulatory, timeline or other concerns to the attention of the Global Study Start-Up Lead and/or Project Team and actively participates in finding solutions. The Global Study Start-Up Associate maintains awareness of local/country agency changes in regulations and forms.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
- Prepares (when applicable) and disseminates regulatory essential document packages to sites.
- Complete review of essential documents following RDQC (Regulatory Document QC).
- Prepare, compile and submit CTAs to Regulatory Authorities and Central IRB/EC (if applicable).
- Including but not limited to communication with regulatory authorities and/or central ethics committees regarding submission strategy and follow up on ongoing submissions under review.
- Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
- Assists GSSU Lead in coordinating efforts for all site activation related activities including but not limited to obtaining and maintaining regulatory and ethics approvals, review and approval of essential documents for RDQC/IP Release
- Prepares ongoing submissions, amendments, and periodic notifications required by central and local IRB/EC, RA, and other local regulatory authorities as needed within the country. Including safety notifications as required by local laws/guidelines, with minimal oversight.
- Responsible for tracking of overall study site status
- Site status and regulatory documentation (including but not limited to RA and IRB/EC submission, meeting dates, approval status/date, and expiration dates as well as other regulatory documents as required).
- Customize country/site specific Patient Information Sheet and Informed Consent Forms.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
- Maintain timelines for site start-up
- Identify site issues (risks) during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
- Escalate risks (e.g. timelines, etc.) to GSSU Lead or PM, as appropriate
- Participates in conference calls and provide necessary Regulatory updates to Study Team and/or Sponsor, as required.
- Facilitates translation of site level documents as required.
- Review translations of regulatory documents, as applicable.
- Provide regular local status updates to SSU Project Lead or PM (as applicable); update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
- Support the development of start-up plans and essential document checklists.
- Act as GSSU Lead on projects with limited scope establishing the CTA submission strategy (Regulatory Authorities and IRB/EC).
- Maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal
- Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements
- Act as Subject Matter Expert (SME) in a specific project, region or country
- Review pertinent regulations and guidance to develop proactive solutions to regulatory submissions issues and challenges
- Facilitates, or assists GSSU Lead (as applicable) with, the registration of and maintenance of ongoing updates for clinicaltrials.gov, if task delegated to Advanced Clinical by Sponsor.
- Occasional travel may be required
- Bachelor's Degree (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience
- 1-2 years experience in a clinical research environment with basic knowledge of clinical processes and documentation
- Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Strong organizational skills
- Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
Equal Employment Opportunity
It is Advanced Group's practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.