What are the responsibilities and job description for the Clinical Research Associate position at CRO Strategies?
Clinical Research Associate (CRA) – Erectile Dysfunction (ED) Clinical Trials
Location : Remote with site travel as needed - MUST BE BOSTON, MA BASED
Employment Type : Contract
Overview :
We are seeking an experienced Clinical Research Associate (CRA) with a strong background in erectile dysfunction (ED) clinical trials . The ideal candidate will have direct experience monitoring studies related to ED treatments, ensuring compliance with regulatory guidelines, and supporting high-quality data collection.
Key Responsibilities :
- Site Monitoring & Management : Conduct site selection, initiation, routine monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
- Regulatory Compliance : Ensure adherence to FDA, ICH-GCP, and site-specific regulations.
- Data Review & Quality Assurance : Verify case report forms (CRFs), source documents, and electronic trial master files (eTMFs) for accuracy and completeness.
- Investigator & Site Support : Provide training and ongoing guidance to site staff on study procedures, protocol adherence, and regulatory compliance.
- Issue Identification & Resolution : Address site-level challenges such as patient enrollment, protocol deviations, and data inconsistencies.
- Stakeholder Communication : Serve as a key liaison between sponsors, investigators, and internal study teams to ensure seamless study execution.
Qualifications :
Preferred Qualifications :
