Clinical Research Associate Job at CRO Strategies, Boston, MA

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  • CRO Strategies
  • Boston, MA

Job Description

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:
  • 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.
Preferred Qualifications:
  • 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.

Job Tags

Contract work, Remote job,

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