Clinical Trial Support Specialist
J
JobgetherClinical Research
BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- 2–3 years
- Required Skills
- GCPHIPAA
Requirements
- 2–3 years of relevant experience supporting clinical trials, research sites, CROs, or sponsors.
- Background in clinical research, medicine, biopharmaceuticals, life sciences, nursing, pharmacy, or healthcare administration.
- 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 like Clinical Research Coordination, Study Startup, Regulatory Support, or Data Coordination.
- Familiarity with clinical research technology such as CTMS, EDC, EMR/EHR, or eRegulatory platforms.
- Strong organizational, documentation, and attention-to-detail skills.
- Excellent written and verbal English communication skills.
- Ability to work independently, reliably, and proactively in a fully remote environment.
- Strong ability to manage priorities, deadlines, and multiple stakeholders.
Responsibilities
- Support clinical trial activities across functional areas including patient engagement, study operations, recruitment, regulatory affairs, and data management.
- Educate and communicate with study participants regarding procedures, visit expectations, informed consent, and adherence.
- Coordinate participant visits, scheduling, transportation, and attendance tracking.
- Maintain accurate information across CTMS, EDC, EMR/EHR, and eRegulatory systems.
- Provide regulatory support by maintaining essential documents, tracking certifications, and preparing for monitoring visits and audits.
- Assist with data entry, query resolution, and protocol deviation tracking.
- Support investigational product compliance and adverse event safety reporting processes.
- Coordinate telehealth and decentralized clinical trial activities, including virtual visits and remote data capture.
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