Clinical Research Associate - CRO Strategies : Job Details

Clinical Research Associate (CRA) – Erectile Dysfunction (ED) Clinical Trials

Location: Remote with site travel as needed - MUST BE BOSTON, MA BASED

Employment Type: Contract

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.

• 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.

• Experience: Minimum 3+ years of CRA experience, with at least 1+ year in erectile dysfunction (ED) clinical trials.
• Education: Bachelor's degree in life sciences, nursing, or a related field required.
• Skills:
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and ED-specific study protocols
• Excellent site management and monitoring abilities
• Ability to work independently and manage multiple sites
• Strong communication and problem-solving skills
• Travel: Willingness to travel as required for site visits.

• Experience in urology, men's health, or sexual dysfunction studies.
• Prior work with CROs, sponsors, or high-volume research sites.
• Certification (e.g., ACRP, SOCRA) is a plus.