Clinical Research Manager

4 days ago

Cambridge, Massachusetts, United States Harvard University Full time
Job Title: Clinical Research Manager

We are seeking a highly skilled Clinical Research Manager to join our team at Harvard University. As a Clinical Research Manager, you will be responsible for overseeing the development, management, and streamlining of our clinical research program.

Key Responsibilities:
  • Develop and implement standard operating procedures for clinical research studies
  • Manage and train a team of clinical research coordinators
  • Conduct internal monitoring of ongoing clinical research studies to ensure protocol and regulatory compliance
  • Manage in-person clinical and human subjects studies, including subject interaction and implementation of study design and controls
  • Ensure compliance with Institutional Review Boards at Harvard and collaborating institutions
  • Oversee corresponding data, database management, and data security in conjunction with SEAS Office of Computing
  • Initiate, prepare, and submit documents to Institutional Review Boards and other governing/regulatory bodies
  • Work closely with principal investigators in planning, execution, and follow-up for all aspects of clinical and human subjects research
Requirements:
  • Bachelor's or advanced degree in physiology, public health, biology, engineering, or a related discipline
  • Three or more years of related experience in clinical research administration or clinical research, or a combination of both
  • Experience working with Institutional Review Boards for human clinical studies, including protocol generation, continuing review, enrollment tracking, and completion of required forms
  • Prior experience managing people is preferred
  • Excellent organizational skills, attention to detail, creativity, and effective communication (oral and written)
  • Ability to work on and track multiple projects and meet deadlines
  • Ability to handle confidential information with discretion
  • Willingness to work at all levels to accomplish team goals
  • Proficient with office productivity software (MS Word, Excel, PowerPoint, etc.)
Preferred Qualifications:
  • Certified Clinical Research Professional (CCRP) certification
  • Experience with participant recruitment and working with patients in a clinical setting, clinical research data entry, and multisite clinical studies
  • Experience with clinical studies involving medical devices, biologics, or drugs
What We Offer:
  • A competitive salary and benefits package
  • A dynamic and collaborative work environment
  • The opportunity to work with a talented team of researchers and professionals
  • Professional development opportunities

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

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