Precision for Medicine
Clinical Research Organization
RegulatoryandSiteStartUpSpecialist
“Regulatory and Site Start Up Specialist at Precision for Medicine. Skills: Regulatory submissions, Site activation, Clinical trial applications. Deliver site activation readiness. Prepare Clinical Trial Application Forms”
What You'll Achieve.
Obtain all necessary authorizations/approvals; Secure on time site activation
Industry & Context.
Risk mitigation
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 (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies, Communication and organizational skills, Experience using computerized information systems, electronic spreadsheets, word processing and 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, Advanced degree in medical or life sciences (MD, PhD, PharmD), RAC certification, Masters in Regulatory Science
What You'll Do.
Deliver site activation readiness
Prepare Clinical Trial Application Forms
Prepare submission dossier
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
Prepare study specific start-up plans
Support development of study specific start-up plans
Prepare IMP release requirements
Support development of IMP release requirements
Prepare essential document review criteria
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 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 readiness
Maintain inspection readiness
File documents as per TMF plan
Support clinical team performing Pre-Study Site Visits
How You'll Work.
Team & Collaboration
Cross-functional teams; Site CRA alignment; Key function communication
Process & Methodology
Project plans, Project trackers
Applying for this Regulatory and Site Start Up Specialist role?
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