Clinical Trial Support Specialist

Accountabilities

• • Support clinical trial activities across one or more functional areas, including patient engagement, study operations, recruitment, regulatory affairs, data management, quality, finance, administration, or sponsor relations.
  • Educate and communicate with study participants regarding procedures, visit expectations, follow-ups, informed consent, adherence, and other study-related requirements.
  • Coordinate participant visits, reminders, transportation, scheduling, attendance tracking, and communication with study teams.
  • Support patient recruitment and pre-screening by conducting outreach, reviewing relevant records, assessing preliminary eligibility, and coordinating screening appointments.
  • Maintain accurate information across CTMS, EDC, EMR/EHR, eRegulatory, and other clinical research systems.
  • Provide regulatory and quality support, including maintaining essential documents, tracking certifications and training, supporting submissions, and preparing for monitoring visits, audits, and inspections.
  • Assist with source documentation, data entry, query resolution, protocol deviation tracking, corrective and preventive actions, and inspection readiness.
  • Support clinical trial agreements, budgets, invoices, reimbursements, stipends, financial tracking, and related administrative processes where applicable.
  • Coordinate communication between sponsors, CROs, investigators, research sites, and other study stakeholders, including meetings, deliverables, action items, and timelines.
  • Support investigational product compliance, including adherence reminders, accountability records, remote temperature monitoring, and escalation of temperature excursions.
  • Assist with study startup, site activation, maintenance, closeout, investigator meetings, and operational milestone tracking.
  • Support adverse event and safety-reporting processes, including documentation, distribution of safety information, and timeline tracking.
  • Coordinate telehealth and decentralized clinical trial activities, including virtual visits, study applications, devices, eConsent, and remote data capture.
  • Provide bilingual or multilingual participant support where applicable, ensuring culturally sensitive communication and appropriate localization of non-medical study materials.

  Requirements

  • 2–3 years of relevant experience supporting clinical trials, research sites, CROs, sponsors, healthcare organizations, or related operations.
  • Background in clinical research, medicine, biopharmaceuticals, life sciences, nursing, pharmacy, allied health, healthcare administration, or an equivalent combination of education and experience.
  • Current and completed GCP and HIPAA training.
  • Familiarity with Good Clinical Practice principles and ICH E6(R3) guidelines.
  • Experience in at least one relevant functional area, such as Clinical Research Coordination, Study Startup, Regulatory Support, Data Coordination, Patient Recruitment, Sponsor/CRO Relations, Healthcare Administration, Quality Assurance, Pharmacovigilance, Telehealth, or Decentralized Clinical Trials.
  • Familiarity with clinical research technology such as CTMS, EDC, EMR/EHR, eRegulatory platforms, or comparable systems.
  • Strong organizational, documentation, and attention-to-detail skills, particularly when handling regulated or audit-sensitive information.
  • Excellent written and verbal English communication skills, with a high level of clarity and professional communication.
  • Ability to work independently, reliably, and proactively in a fully remote environment.
  • Strong ability to manage priorities, deadlines, documentation, and multiple stakeholders.
  • Multilingual capabilities are highly desirable.
  • Applicants should be prepared to identify their strongest functional areas, relevant years of experience, clinical research systems used, languages and proficiency levels, and preferred work arrangement.
  • Three professional references from previous clinical trial positions may be required, along with background checks where applicable.
  • A short introductory video may be requested as part of the application process.

  Benefits

  • Remote work with opportunities available on a full-time, part-time, or project-based basis.
  • Opportunity to work with clinical research sites, sponsors, CROs, and healthcare organizations across different studies and therapeutic environments.
  • Exposure to multiple areas of the clinical trial lifecycle and opportunities to leverage your existing specialization.
  • Flexible engagement opportunities depending on study and operational requirements.
  • Opportunity to contribute to ethical, scientifically rigorous research supporting the development of new treatments.
  • Collaboration within a global, multidisciplinary clinical research support environment.
  • Potential for professional growth as new clinical trial opportunities and assignments become available.