Principal Investigator - Cro

Mantell Associates is partnered with a highly-regarded CRO who are seeking a Principal Investigator to join their skilled team and contribute to their ongoing research initiatives.

As Principal Investigator you will conduct and coordinate daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Work with a local and central team driving clinical oversight and the quality of the assigned studies at the site.

Principal Investigator - Responsibilities:

• Collaborate with interdisciplinary teams to effectively communicate research findings and contribute to scientific publications
• Act as key source of knowledge/information on understanding of the medical environment, company's & competitor's product data and unmet medical needs.
• Oversee the implementation of research activities, including participant recruitment, data collection, and analysis
• Ensure compliance with regulatory agencies and ethical standards throughout the research process
• Drive and act as supervisor for local Clinical trials
• Provide guidance and mentorship to junior researchers and study staff
• Ensure compliance of all Medical Affairs activities with Code of Conduct, internal SOPs and all relevant local legal regulations.
• Design and execute clinical research studies in accordance with study protocols, regulatory requirements, and ethical guidelines

Principal Investigator - Requirements:

• Bi-lingual Spanish/English preferred
• A doctoral degree (Ph.D., M.D., or equivalent) in a relevant field
• CPR required / ACLS preferred
• Possesses extensive experience in clinical research and a passion for advancing medical knowledge
• Proficiency in study design, data analysis, and interpretation of research results
• Strong communication and interpersonal skills to effectively collaborate with colleagues and stakeholders
• 2 years in medical research as PI/Sub-PI
• In-depth knowledge of clinical research regulations, including FDA and ICH guidelines
• Proven experience as a Principal Investigator or substantial involvement in clinical research studies
• Board Certification preferred

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 485 1298.