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Premier Research
Premier Research
1001 – 5000 Darbinieki
H1B vīzas sponsorsBiotehnoloģijaKonsultācijasVeselības aprūpe
Premier Research works with biotechnology companies to move promising science toward new medical treatments. The clinical research and development company supports product development and regulatory planning across areas including oncology, hematology, rare diseases, cell and gene therapy, and pediatrics. Its teams help guide therapies through clinical development and the path toward regulatory approval, with particular experience in rare diseases and innovative treatments.
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Vakances uzņēmumā

Site Solutions Executive, Clinical Trials

Coordinate clinical trial compliance, documentation, and patient procedures at Premier Research’s Bangalore site. Support investigators, sponsors, and CROs throughout study delivery.

INIndijaKlātienēPilna slodzeVidējais līmenisVecākais speciālistsNepieciešamā Valoda: angļuVadošais darbinieks
Google Cloud Platform

Apraksts

  • Coordinate site clinical trials in line with study protocols, GCP guidelines, and local regulations.
  • Help the Principal Investigator and study team meet sponsor and regulator requirements.
  • Review site workflows, identify gaps, and assist with implementing process improvements.
  • Enter Case Report Form and Electronic Case Report Form data in consultation with the investigator.
  • Maintain study records, including the Trial Master File.
  • Prepare for and support site initiation, monitoring, close-out, patient, quality assurance, sponsor, and inspection visits.
  • Report site performance metrics at scheduled intervals.
  • Coordinate ethics committee submissions and maintain associated records.
  • Help schedule patient investigations and assessments.
  • Under the Principal Investigator’s supervision, manage the availability, storage, tracking, and dispensing of investigational products, lab kits, and trial supplies.
  • Complete site activities required by protocols, contracts, and ethics committees accurately and on time.
  • Arrange laboratory sample pickups and reporting.
  • Transcribe source documents and obtain their review and sign-off when required.
  • Help resolve data queries promptly.
  • Coordinate protocol procedures with the Principal Investigator, including participant scheduling, screening, and enrollment.
  • Keep the site monitor informed about enrollment, visits, dosing, and dispensing.
  • Coordinate communication between investigators and sponsors or CROs.
  • Support patient awareness, training, and other site or community events.
  • Assist with feasibility work and epidemiological data collection.
  • Build a database of potential participants who may qualify for study enrollment.
  • Identify challenges and develop mitigation plans with the LM, TSM, and Principal Investigator.
  • Complete required and ongoing training modules and SOPs.
  • Notify sponsor or CRO representatives about external audits and inspections.
  • Work with the Principal Investigator to address audit findings and carry out approved recommendations.
  • Escalate systemic non-compliance or misconduct to the manager.
  • Refer site feasibility requests to the CS feasibility team.

Prasības

  • Bachelor’s or master’s degree in clinical, biological, or mathematical sciences or a related field; alternatively, a medical or dental degree or nursing qualification.
  • Candidates who do not meet the education requirement need at least four years of experience working at clinical research sites.
  • Strong spoken and written English skills and fluency in at least one local Indian language.
  • Excellent interpersonal skills.
  • Effective coordination and organizational abilities.
  • Problem-solving and analytical capabilities.
  • Careful documentation and attention to detail, including awareness of timelines and clinical trial data accuracy.
  • Understanding of clinical trial ethics and scientific standards, patient safety, and patient rights.
  • Comfort using computers and standard office communication tools.

Priekšrocības

  • Flexible working arrangements intended to accommodate personal needs.
  • Opportunities to build skills and advance professionally.

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