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Lead Clinical Research Specialist

2 months ago

Bristol, Maine, United States Medpace Full time
Position Overview:

We are looking for a dedicated and experienced Senior/Principal Clinical Research Associate to enhance our Clinical Operations team. This role is crucial for executing projects that contribute significantly to our organizational success. If you are eager to leverage your expertise and further your career in a dynamic environment, this position may be the right fit for you.

At Medpace, we foster a culture of expertise, empowering our teams to utilize their unique skills and experiences in a proactive manner. Our employees exemplify our values and commitment to client service, working diligently to meet high expectations and challenges. In return, we offer engaging projects, opportunities for career advancement, and recognition within our global network.

Key Responsibilities:
  • Ensure the protection of subjects' rights and well-being, verifying that trial data is accurate, complete, and verifiable from source documents, while adhering to approved protocols, GCP, and relevant regulatory requirements;
  • Oversee site compliance during qualification, study initiation, routine monitoring, and study site close-out visits, in accordance with Medpace/Sponsor Standard Operating Procedures (SOPs);
  • Act as the primary resource for clinical investigators and site personnel;
  • Maintain effective collaboration and communication with internal cross-functional teams at Medpace;
  • Guarantee the quality completion of visit reports, follow-up letters, and the upkeep of study-related databases and ClinTrak Monitoring Portal.
Qualifications:
  • Bachelor's degree in a health or science-related discipline with a minimum of 5 years of clinical monitoring experience;
  • In-depth knowledge of clinical monitoring practices and procedures, with practical application of this expertise;
  • Proven ability to function as a Lead CRA when applicable, serving as a resource and mentor for new CRAs;
  • Proactively implement innovative ideas and solutions within the scope of authority.
About Medpace:

Medpace is a comprehensive clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device sectors. Our mission is to expedite the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across various domains, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system, anti-viral, and anti-infective.

Why Choose Medpace?

Our commitment to People, Purpose, and Passion drives us to make a meaningful difference in the lives of patients and families affected by numerous diseases. The work we undertake today will have a lasting impact on those living with illness in the future.

Medpace Benefits:
  • Flexible hybrid work-from-home options;
  • Competitive paid time off packages;
  • Company-sponsored employee appreciation events;
  • Health and wellness initiatives for employees;
  • Flexible work schedules;
  • Attractive compensation and benefits package;
  • Structured career paths with professional growth opportunities.
Awards and Recognition:
  • Ranked by Forbes as one of America's Most Successful Midsize Companies in recent years;
  • Consistently honored with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility.
Next Steps:

A member of the Medpace team will review your qualifications and, if there is mutual interest, you will be contacted with further details.