Company: Indero
Location: Remote, United States (North Central: Illinois, Indiana, Michigan, Ohio, Wisconsin and/or East Coast)
Employment Type: Permanent | Full-Time
Industry: Clinical Research | CRO | Dermatology | Rheumatology
Experience Required: Minimum 5+ years of on-site clinical monitoring experience in biotech, pharmaceutical, or CRO environments
Position Overview
A globally recognized dermatology and rheumatology-focused CRO is seeking a highly experienced Senior Clinical Research Associate (CRA) to support clinical trials across the North Central U.S. region and/or the East Coast. This remote-based role requires regional travel and offers the opportunity to deepen therapeutic expertise in dermatology and rheumatology clinical research.
The Senior CRA will oversee site monitoring activities to ensure that clinical studies are conducted, documented, and reported in full compliance with study protocols, sponsor SOPs, ICH-GCP guidelines, and applicable U.S. regulatory requirements.
This position is ideal for seasoned CRAs who excel in autonomous work environments, consistently deliver high-quality results, and seek to contribute within a specialized mid-sized CRO.
Key Responsibilities
Conduct site qualification, site initiation, routine monitoring, and close-out visits in accordance with monitoring plans and regulatory standards.
Perform source data verification (SDV) and ensure protocol adherence.
Verify investigational product storage, dispensing, and accountability procedures.
Review essential regulatory documents for completeness and compliance.
Prepare detailed monitoring visit reports and follow-up communications.
Participate in investigator meetings and sponsor discussions.
Build strong relationships with investigators and site teams to support enrollment and retention targets.
Ensure patient safety, data accuracy, and study integrity at all assigned sites.
Lead CRA Responsibilities (As Applicable)
Review and approve monitoring visit reports submitted by CRAs.
Track monitoring metrics and escalate risks to project teams.
Contribute to the development of monitoring plans and annotated visit report templates.
Mentor junior CRAs and support training initiatives.
Conduct on-site quality control visits.
Collaborate with project management teams to resolve operational challenges.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Nursing, or a related clinical research field.
Equivalent relevant clinical research experience may be considered.
Experience:
Minimum 5+ years of independent on-site monitoring experience in biotechnology, pharmaceutical, or CRO settings.
Prior exposure to rheumatology clinical trials required.
Dermatology clinical trial experience strongly preferred.
Core Skills & Competencies
Strong knowledge of ICH-GCP guidelines and U.S. regulatory frameworks.
Excellent written and verbal communication skills.
Ability to manage multiple clinical studies and competing priorities.
Strong analytical thinking, risk assessment, and problem-solving capabilities.
High attention to detail and quality-driven mindset.
Proficiency in Microsoft Office applications.
Ability to travel approximately 65% within assigned geographic regions.
About the Organization
Indero is a global clinical research leader specializing in dermatology and rheumatology. With over 25 years of experience, the organization delivers comprehensive CRO services including protocol design, site management, patient recruitment, clinical monitoring, biometrics, pharmacovigilance, and regulatory consulting.
Operating across North America, Europe, Asia Pacific, and Latin America, the company partners with biotech and pharmaceutical sponsors to deliver scientifically rigorous and operationally efficient clinical trials worldwide.
Work Environment & Career Growth
The organization fosters a collaborative and innovation-focused culture where expertise is recognized and career progression is supported. Professionals gain deep therapeutic exposure while contributing to high-impact global clinical programs.
Equal Opportunity Statement
The organization is committed to equitable treatment and equal opportunity for all applicants. Reasonable accommodations are available throughout the recruitment process upon request.
Applicants must be legally authorized to work in the United States.
Apply via ThePharmaDaily.com
If you are a Senior Clinical Research Associate with strong rheumatology and dermatology experience seeking a remote U.S.-based opportunity within a specialized global CRO, apply now through ThePharmaDaily.com to advance your career in regulatory-compliant clinical trial monitoring.
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