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Alcedis - a HUMA company · 1 day ago

Clinical Research Associate / Clinical Monitor / Site Manager – Home-Based (Eastern U.S.)

Atlanta, GA

Full-time

Hybrid

Mid Level

$75K/yr - $95K/yr

3+ years exp

Alcedis, a HUMA company, is an innovative research institute providing clinical research services with a modern information technology infrastructure. They are seeking a Clinical Research Associate / Clinical Monitor / Site Manager to join their Clinical Operations team, where the role involves site monitoring activities and ensuring protocol compliance at investigational sites in the U.S. and potentially Canada.

Clinical TrialsHealth CareMedicalSoftware

Responsibilities

Provide on-site and remote support in the organization and conduct of the study and supervision of the investigators

Prepare, conduct and follow-up of site initiation, monitoring and close-out visits (remote or on-site)

Assess study progress at assigned sites according to predefined guidelines and ensure complete, accurate documentation

Validate study data collected by investigators (source data verification)

Prepare monitoring visit reports and related documentation

Evaluate study sites for compliance with applicable regulations, guidelines, and study protocols

Collaborate closely with data manager and project manager

Generate, track, and resolve queries

Train investigators and study coordinators in the use of EDC systems

Conduct feasibility assessments for new study sites and upcoming projects

Support and coordinate study sites, including assistance with documentation and escalation of site-level issues

Prepare documents for submission to regulatory authorities and ethics committees

Qualification

GCP monitoring experienceData privacy regulationsBachelor’s degree in sciencesStudy Nurse certificationEnglish proficiencyCommunication skillsOrganizational skillsTeam-oriented mindset

Required

Bachelor's degree in natural or life sciences or a comparable qualification (e.g., Study Nurse certification)

At least 3 years of hands-on monitoring experience in GCP-regulated interventional clinical trials

Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus

Ability to work independently, plan proactively, and execute tasks with foresight and attention to detail

Strong communication and organizational skills

Collaborative, team-oriented mindset

Excellent written and spoken English

Willingness to travel and flexibility to support study needs