Position: Clinical Research Associate (CRA)
Location: Charleston, SC, United States
Job Category: Clinical Research
Role Overview:
The Clinical Research Associate (CRA) is responsible for ensuring the protection of trial participants' rights and the accuracy, completeness, and verifiability of trial data. The CRA acts as the primary contact between Investigational Sites, Novotech, and the Sponsor. They are key to managing relationships at the site level and ensuring clinical trials are conducted in compliance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Key Responsibilities:
As a CRA, you will:
Relationship Management: Build and maintain strong relationships with Principal Investigators, study coordinators, pharmacists, and other site personnel to ensure smooth and efficient trial management.
Study Coordination: Collaborate with In-house Clinical Research Associates (IHCRA) and Regulatory Start-Up Associates (RSA) to prepare essential site documents and support regulatory submission processes.
Site Recruitment & Engagement: Lead site recruitment efforts, develop site-specific recruitment plans, and ensure participant enrollment meets targets.
Monitoring Visits: Conduct monitoring visits at investigational sites across all phases of the trial, including Site Selection, Site Initiation, Monitoring, and Site Closeout. This includes both onsite and remote visits.
Participant Safety: Ensure participants’ rights and wellbeing are protected, confirm consent form checks, patient eligibility, and protocol compliance, and report adverse events (AEs) and serious adverse events (SAEs) to the sponsor.
Data Verification: Verify the accuracy and completeness of trial data, resolve data queries, and ensure CRF data is entered on time per the Clinical Monitoring Plan (CMP).
Drug Accountability: Ensure that investigational drugs are stored, dispensed, accounted for, and reconciled in accordance with the CMP and protocol.
Minimum Qualifications & Experience:
The ideal candidate should have:
A graduate degree in a clinical or life sciences-related field, or equivalent relevant qualifications/experience.
At least 2-3 years of experience as a Clinical Research Associate in the clinical industry.
Excellent time management and attention to detail.
Strong interpersonal and teamwork skills with a commitment to contributing to innovative treatments.
Proficiency in using computer systems and clinical software.
Salary Range
$80,000 - $125,000 USD (Salary will be based on the candidate's experience level).
About Novotech:
Novotech is a full-service Clinical Contract Research Organization (CRO) with a strong global presence. The company has managed over 3,700 clinical projects across all clinical trial phases (Phase I-IV) and offers services like feasibility assessments, ethics submissions, data management, and medical monitoring. Headquartered in Sydney, Australia, Novotech operates across Asia-Pacific, North America, and Europe.
Employee Benefits:
At Novotech, we offer a flexible, inclusive work environment with benefits such as:
Flexible working options.
Paid parental leave for both parents.
Wellness programs and ongoing professional development opportunities.
Support for diversity, including individuals who identify as LGBTIQ+, have a disability, or have caregiving responsibilities.
Application Details:
Location: 22 Westedge Drive, Suite 500, Charleston, SC 29403, United States
Job Schedule: Full-Time
Posting Date: September 26, 2024
To apply, click on Apply Now and follow the application steps.
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