Clinical Research Associate / Clinical Monitor / Site Manager – Home-Based (Eastern U.S.)
About The Position
As an innovative research institute, Alcedis provides clinical research services supported by a modern information technology infrastructure. Our flat hierarchies and collaborative culture foster a flexible, dynamic, and team-oriented working environment. We are seeking a Clinical Research Associate / Clinical Monitor / Site Manager (home-based) to join our Clinical Operations team. In this role, you will play a key part in site monitoring activities and in ensuring protocol compliance and overall study quality at investigational sites. You will independently monitor U.S. study sites and may also support Canadian sites as needed, working in close and regular contact with the responsible Project Manager or Lead Clinical Research Associate at Alcedis in Germany or the United States. We are looking for candidates based in the Eastern United States, ideally in or near major metropolitan areas such as Boston, New York City, Philadelphia, Pittsburgh, Columbus, Detroit, Atlanta, or Raleigh–Durham. Candidates located in other parts of the Eastern U.S. will also be considered.
Requirements
- 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
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
Benefits
- Annual salary: $75,000 – $95,000 DOE
- 15 days of paid vacation per year
- 6 paid sick days per year
- Health, dental and vision insurance for you and your dependents
- Employee life insurance
- Health Savings Account (HSA)
- 401(K)
- You'll work in a future-oriented and secure working environment
- A forward-looking, growth-oriented work environment
- Exciting and challenging projects that make an impact
- Flat organizational structure with an open and collaborative culture
- A dedicated, successful, and supportive team environment
- Varied work with the autonomy to take ownership of your projects
- Flexible working hours to support work-life balance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
