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Lead Clinical Research Specialist

2 months ago


San Diego, California, United States VENESCO LLC Full time
Become a Key Player as a Lead Clinical Research Specialist

VENESCO LLC is seeking three dedicated Lead Clinical Research Specialists to enhance our research team. In this pivotal role, you will contribute significantly to the management of clinical research initiatives while ensuring adherence to all relevant regulations and organizational policies.

Key Responsibilities:
  • Collaborate closely with the Principal Investigator and Clinical Investigation Division to supervise clinical research operations.
  • Support the creation of training materials for study team members.
  • Verify that all research personnel fulfill necessary training criteria.
  • Engage in compliance and monitoring activities.
  • Assist in evaluating study feasibility and developing research protocols.
  • Prepare documentation for regulatory submissions.
  • Maintain organized study files and documentation.
  • Facilitate participant recruitment and the informed consent process.
  • Collect and oversee study data management.
  • Communicate study requirements effectively to team members.
  • Report any instances of research misconduct.
  • Contribute to scientific and compliance reporting.
  • Adhere to all federal regulations and internal policies.
Qualifications:
  • Master's degree in a healthcare-related discipline.
  • A minimum of 2 years of experience in a senior research coordination role.
  • Proven project management and budgeting expertise.
  • Proficient in MS Office and possess strong computer skills.
  • Exceptional written and verbal communication abilities.
  • Familiarity with auditing policies and HIPAA regulations.

Join our organization and contribute to a workplace that values diversity and equal opportunity. We are committed to fostering an inclusive and supportive environment for all team members.