Precision for Medicine
Clinical Research
RegulatoryandSiteStartUpSpecialist
“Regulatory and Site Start Up Specialist at Precision for Medicine. Skills: Regulatory affairs, Site start-up, Clinical trial applications, Competent Authority submissions. Deliver site activation readiness. Mitigate site activation risks”
What You'll Achieve.
Timeliness of site activation; Quality of site activation
Industry & Context.
Foreseeing risks; Mitigating risks
What They're Looking For.
Must Have
Bachelor's degree in life sciences or related field, Registered Nurse (RN) or equivalent combination of education, training, and experience, 1 year or more as a Regulatory or SU specialist, Experience using computerized information systems, Experience using electronic spreadsheets, Experience using word processing, Experience using electronic mail, Fluency in English
Nice to Have
Qualification in Pharmacy/work experience as a Pharmacist, Relevant regulatory and site start-up experience, Experience using milestone tracking tools/systems, Ability to prioritize workload to meet deadlines, Advanced degree in medical or life sciences, RAC certification, Masters in Regulatory Science
What You'll Do.
Deliver site activation readiness
Mitigate site activation risks
Prepare Clinical Trial Application Forms
Prepare submission dossier
Submit to Competent Authorities
Submit to Ethics Committees
Interact with CA/EC for study purposes
Handle responses to CA/EC
Provide updates about CA and EC submissions
Maintain project plans
Maintain project trackers
Maintain regulatory intelligence tools
Support development of study specific start-up plans
Support development of IMP release requirements
Support development of essential document review criteria
Partner with assigned site CRA
Manage collection of essential documents
Customize country/site specific Patient Information Sheet
Customize country/site specific Informed Consent Form
Facilitate translation of documents
Coordinate translation of documents
Maintain communication with key functions
Act as SME for site level critical path
Collect site level critical path data points
Maintain site level critical path data points
Support negotiation of study budgets
Support execution of investigator contracts
Participate in feasibility group
Support feasibility group in site outreach
Assess potential investigator interest
Keep updated knowledge of local clinical trial laws
Keep updated knowledge of local regulations
Distribute knowledge within PFM
Maintain audit/inspection readiness
File documents as per TMF plan
Support clinical team performing Pre-Study Site Visits
How You'll Work.
Team & Collaboration
Start Up Lead; Regulatory Lead; Project Manager; Project Team; Site CRA; Feasibility; Clinical Operations; Project Management; Regulatory; Site Contracts management group; Site Contract Management department
Communication Scope
Organizational skills
Process & Methodology
Project plans, Project trackers
Applying for this Regulatory and Site Start Up Specialist role?
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