Principal Investigator - CRO

Posted 21 August 2023
Salary Negotiable
LocationSouth Carolina
Job type Full Time
DisciplineClinical & DataCRO & Clinical Operations
Contact NameStephanie Moreno

Job description

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:

  • 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 - 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 +44 (0)20 3854 7700.