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Senior Clinical Research Specialist

2 months ago


New Brunswick, New Jersey, United States Allen Spolden Full time
Position Overview
As a Senior Clinical Research Specialist at Allen Spolden, you will play a pivotal role in supporting clinical trials by providing comprehensive research assistance. This position involves collaboration with the clinical study team under the guidance of a supervisor or designated leader.

Key Responsibilities
  • Contribute to the design and formulation of study protocols and case report documentation.
  • Develop clinical Standard Operating Procedures (SOPs), policies, charters, and plans in accordance with both national and international regulations.
  • Assist in the assessment of potential clinical sites based on predefined acceptability criteria.
  • Manage the procurement of budgets, contracts, regulatory paperwork, and other essential administrative documents related to clinical research activities.
  • Initiate studies by conducting site initiation visits and coordinating the shipment of clinical supplies, case report forms, and other required materials.
  • Perform ongoing monitoring of studies, which includes regular site visits, checks for protocol compliance, handling of materials, and review of study documentation.
  • Compile site visit reports that highlight key achievements, issues needing resolution, and recommendations for follow-up actions for assigned study sites.
  • Conduct study closure visits, gather final reports from investigators, and assist in the preparation of final reports for regulatory submission.
  • Support the maintenance of clinical archives and electronic documentation.
  • Undertake additional tasks as assigned.
Qualifications
To excel in this role, candidates must demonstrate the ability to effectively fulfill each essential duty. The qualifications listed below represent the necessary knowledge, skills, and abilities required for this position. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential functions.
  • Bachelor's degree in a relevant field (BA, BS, RN, BSN or equivalent).
  • Fundamental understanding and adherence to Good Clinical Practices (GCP).
  • A minimum of 5 years of experience in clinical research.
  • Exceptional attention to detail.
  • Capability to manage multiple tasks simultaneously.
  • Unwavering integrity and adherence to the highest ethical standards.
  • Outstanding written and verbal communication skills.
  • Self-driven, assertive, and motivated.