Start Up Specialist – Remote CRO Role in Eastern Europe — Columbus

Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.

As our company continues to grow, we are seeking a Start Up Specialist to join our growing team. We are open to candidates at all levels who have acquired some Site Start Up experience gained from within a Clinical Research Organisation.

We are open to candidates located in Hungary, Poland, Serbia, Slovakia, or Romania with fluency in Hungarian.

Essential functions of the job include but are not limited to:

• Preparation of Clinical Trial Application Forms as well as preparation of submission dossiers (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of Clinical Trials according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team.
• Maintenance of project plans, project trackers and regulatory intelligence tools as pertains to assigned responsibilities, keeping Regulatory Leadership informed.
• Preparation/support of the development of study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication and secure site review; manage collection of essential documents required for site activation/IMP release.
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating in country start-up (e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group) on project-specific status and deliverables.
• Act as SME for collection and maintenance of site-level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements, and other required reviews to secure on-time site activation for assigned sites in the country.
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under direction of the Site Contract Management department/designee.
• May participate/support the feasibility group in site outreach to assess potential investigator interest in a potential study.
• Maintain up-to-date knowledge of local clinical trial laws and regulations, and help distribute this knowledge within the organization to ensure conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study-specific plans in the relevant TMF.
• May support the clinical team in performing Pre-Study Site Visits.

The ideal candidate will have:

Minimum Required:

• Bachelor's degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN), or equivalent combination of education, training, and experience.
• A qualification in Pharmacy/work experience as a Pharmacist would be highly beneficial.
• Demonstrated experience as a Regulatory or Start Up Specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

Other Required:

• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail.
• Must be fluent in both Hungarian and English, as you will be supporting Hungarian sites.

Preferred:

• Relevant regulatory and site start-up experience (feasibility, contract negotiations, CA/EC/IRB submissions).
• Experience using milestone tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, or Masters in Regulatory Science.

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.