Regulatory and Site Start Up Specialist

🔥 5 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Deliver timely and high-quality site activation readiness within assigned countries/sites and foresee and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams • Maintain project plans, project trackers, and regulatory intelligence tools • Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents required for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Facilitate document translations and coordinate translation activities • Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams • Act as subject matter expert for site-level critical-path and site-activation data points • Support study budget negotiations and investigator contract execution when required • Support feasibility site outreach when needed • Maintain current knowledge of local clinical trial laws and regulations and distribute knowledge within the company • Maintain audit/inspection readiness and file documents according to TMF and study-specific plans • Support Pre-Study Site Visits when needed • Support process improvement initiatives, training, and mentoring • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 1 year or more as a Regulatory or Site Start-Up specialist or comparable role in a CRO, pharmaceutical, or biotech industry, or equivalent relevant experience and/or demonstrated competencies • Strong communication and organizational skills • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Fluency in English and, for non-English-speaking countries, the local language of the country where the position is based • Candidates must be legally authorized to work in the country of employment without employer sponsorship • Preferred: relevant regulatory and site start-up experience for the particular country • Preferred: experience using milestone tracking tools/systems • Preferred: ability to prioritize workload to meet deadlines • Preferred: advanced degree in medical or life sciences, RAC certification, or Master’s in Regulatory Science

🏖️ Benefits

• Regular full-time employment • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities