Clinical Research Coordinator

SiteBridge Research, Inc.

Lufkin, TXFull-time

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Qualifications

  • •Requires Bachelor’s degree in a relevant life science discipline
  • •3+ years of previous experience working in clinical site/trials
  • •Knowledge of FDA & ICH GCP regulations and guidelines is required
  • •Detail-oriented and meticulous in all aspects of work
  • •Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
  • •Knowledge of standard clinical procedures and protocol
  • •Analytical mindset: needs analytical skills to collect and interpret data, taking note of patterns or outcomes that those in charge of the trial need to be aware of
  • •Excellent interpersonal skills, with the ability to effectively communicate and resolve issues while working with the PI, participants, and key stakeholders
  • •Exceptional written and verbal communication skills, with the ability to clearly convey study requirements to participants and effectively liaise with site and management staff
  • •Skilled with standard computer programs including the MS Office suite
  • •7 more items(s)

Responsibilities

  • •The Clinical Research Coordinator supports the clinical Principal Investigator (PI) and Clinical Research Nurse across multiple ongoing research studies
  • •In this role, the study coordinator assists and facilitates daily clinical trial operations, playing a key part in successful study execution
  • •The role involves close collaboration with the site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, optimize site efficiency, and support timely study completion
  • •Communicate with study participants regarding study objectives
  • •Conduct questionnaire administration and monitor participant compliance with study protocols
  • •Oversee study activities to ensure adherence to protocols, ethical conduct, and applicable regulatory standards
  • •Maintain research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines
  • •Manage clinical study and staff records related to clinical study activity
  • •Manage participant screening and recruitment by scheduling study visits, obtaining informed consent, and conducting protocol-required intake assessments
  • •Track and manage participant enrollment across all site clinical studies
  • •Prepare trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports
  • •Maintain compliance of clinical studies with applicable local, state, and federal regulations, in alignment with ICH/GCP guidelines
  • •Create, organize, and maintain essential study documentation and records to ensure accuracy and compliance
  • •Communicate ongoing study progress to the Clinical PI and Site Operations leads, including updates on recruitment, compliance, and overall study performance
  • •Stay updated on the latest research protocols and regulatory requirements to ensure compliance and contribute to the successful completion of the study
  • •Willingness to travel up to 25% as needed
  • •13 more items(s)
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