Clinical Research Associate: Study Start-Up & Documentation Pro

Scorpion Therapeutics; Malvern (Chester County); On-site; USD 80,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Trials Administrative Specialist to support study start-up, execution, maintenance, and close-out for assigned trials. You will assist with investigator/site identification, feasibility, and recruitment, and maintain study document trackers and TMF integrity.

You will collaborate with CRAs/CTMs on vendor oversight, regulatory submissions, and inspection readiness, while ensuring timelines and budgets are managed and complied with SOPs.

Qualifications

• Excellent communication and collaboration skills; team-oriented approach.
• Experience with eTMF, CTMS, and EDC (MS Project or Smart sheets timelines desired).
• CRO/vendor management experience preferred.
• Experience in Ophthalmology and/or advanced therapy studies in Phases 1–3 desired.

Responsibilities

• Support study start-up, execution, maintenance, and close-out for assigned clinical trials.
• Assist with investigator/site identification, feasibility, and recruitment.
• Develop and maintain study document version tracker; ensure document control and accuracy.
• Upload study documents in CTMS and Trial Master File (TMF).
• Track investigational product shipments, returns, and destruction; ensure TMF documentation.
• Track and maintain subject enrollment; bioanalytic sample inventory, shipments, receipt; database queries and resolution.
• Support CRAs/CTMs with study management (vendor oversight, investigator meeting planning, scheduling study team meetings with agenda and minutes).
• Coordinate with CRAs to review, maintain, and reconcile essential regulatory/study documents for inspection readiness and ICH-GCP/SOP compliance.
• Perform routine TMF quality control reviews and coordinate reconciliation with field CRAs.
• Support investigational sites with regulatory submissions, IRB/IEC communications, and study documentation.
• Act as a point of contact for site questions, timelines, and operational support.
• Manage subject travel reimbursement; coordinate site activation (prepare Investigational Site Green Light for CTM sign-off).
• Prepare/maintain operational documents (study plans, monitoring guidelines, site manuals, templates, training materials).
• Review informed consent forms and essential documents for completeness, quality, and compliance.
• Collaborate cross-functionally with teams/vendors to support deliverables.
• Identify/escalate study risks/issues and out-of-scope activities to study manager; ensure compliance with protocols/Clinical Management Plans/SOPs/regulations.
• Support inspection/audit readiness; assist with budget tracking and invoice reconciliation.
• Conduct ongoing eTMF maintenance (filing, QC, reconciliation, missing-document follow-up).
• Support safety review documentation/data collection; develop/implement risk mitigation; may assist with SOP policy/procedure development.

Skills

Communication

Collaboration

Teamwork

eTMF

CTMS

EDC

Vendor management

Ophthalmology

Advanced therapies

Tools

CTMS

eTMF

EDC

MS Project

SmartSheets

Job description

Scorpion Therapeutics is seeking a Clinical Trials Administrative Specialist to support study start-up, execution, maintenance, and close-out for assigned trials. You will assist with investigator/site identification, feasibility, and recruitment, and maintain study document trackers and TMF integrity.

You will collaborate with CRAs/CTMs on vendor oversight, regulatory submissions, and inspection readiness, while ensuring timelines and budgets are managed and complied with SOPs.