Senior Clinical Research Coordinator

4 weeks ago

Lexington, Massachusetts, United States Massachusetts General Hospital(MGH) Full time
Job Summary

The Senior Clinical Research Coordinator will work independently to oversee a portfolio of clinical research projects under minimal guidance from the Principal Investigator (PI) in the Lurie Center for Autism Division at Massachusetts General Hospital (MGH). The successful candidate will be responsible for leading the development, implementation, and analysis of clinical research projects, ensuring adherence to quality, safety, and IRB requirements.

Key Responsibilities
  • Design and implement research protocols in conjunction with the PI, recommending protocol changes and assisting with writing protocols and manuscripts.
  • Conduct literature searches and assist the PI in leading regulatory activities, including writing consent forms, filing adverse events, and preparing reports and annual reviews.
  • Develop study documents, including protocol and informed consent forms, study manuals, source documentation templates, recruitment materials, and other study tools.
  • Collaborate with project investigators and other research sites to ensure targets are met for study start-up, site activation, patient recruitment, and enrollment.
  • Develop and implement recruitment strategies, verifying subject inclusion/exclusion criteria and confirming subject eligibility.
  • Collect and organize patient data, document patient visits and procedures, administer and score questionnaires, and maintain records and databases.
  • Ensure study-related regulatory documents are properly maintained, facilitate integration of regulatory issues to ensure safe practice, and coordinate lab activities.
  • Supervise and educate staff, interns, and volunteers, promoting collaboration and a work environment conducive to teamwork and employee satisfaction.
  • Support grant management responsibilities, including developing study budgets and working closely with Grants Management on study budget-related questions and invoicing.
Qualifications
  • Ability to design, prepare, deliver, and evaluate clinical programs.
  • High-level time management and organization skills.
  • Excellent written and verbal communication skills.
  • Administrative skills to meet regulatory requirements.
  • Ability to prepare and monitor budgets.
  • Knowledge of current and developing clinical research trends.
  • Ability to meet the requirements of varying funding sources.
  • Sound interpersonal skills and the ability to supervise others.
  • Ability to work independently and display initiative to introduce innovations to research studies, as well as be a team player.
  • Ability to identify problems and develop solutions.
  • Ability to make independent, effective decisions.
  • Strong database management and overall computer skills with the ability to resolve technical problems.
  • Demonstrated analytical skills to problem-solve effectively, including technical matters.
  • Ability to demonstrate respect and professionalism for subjects' rights and individual needs.
Education and Experience

Bachelor's degree required; MA/MS/MPH preferred. Certified Clinical Research Coordinator (CCRC) certification preferred. 3-5 years of directly related experience required.

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.

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