Mantell Associates is partnered with a highly-regarded CRO who are seeking a Principal Investigator, Internal Medicine to join their skilled team and contribute to their ongoing research initiatives.
As Principal Investigator, Internal Medicine 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 to drive clinical oversight and the quality of the assigned studies at the site.
Principal Investigator, Internal Medicine - Responsibilities:
Design and execute clinical research studies in accordance with study protocols, regulatory requirements, and ethical guidelines
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
Collaborate with interdisciplinary teams to effectively communicate research findings and contribute to scientific publications
Provide guidance and mentorship to junior researchers and study staff
Drive and act as supervisor for local Clinical trials
Ensure compliance of all Medical Affairs activities with Code of Conduct, internal SOPs and all relevant local legal regulations.
Act as key source of knowledge/information on understanding of the medical environment, company's & competitor's product data and unmet medical needs.
Principal Investigator, Internal Medicine - Requirements:
A doctoral degree (Ph.D., M.D., or equivalent) in a relevant field
2 years in medical research as PI/Sub-PI
CPR required / ACLS preferred
Board Certification preferred
Bi-lingual Spanish/English preferred
Proven experience as a Principal Investigator or substantial involvement in clinical research studies
In-depth knowledge of clinical research regulations, including FDA and ICH guidelines
Proficiency in study design, data analysis, and interpretation of research results
Strong communication and interpersonal skills to effectively collaborate with colleagues and stakeholders
Possesses extensive experience in clinical research and a passion for advancing medical knowledge
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.