Principal Investigator - Cro
By Mantell Associates At South Carolina, United States
Possesses extensive experience in clinical research and a passion for advancing medical knowledge
Design and execute clinical research studies in accordance with study protocols, regulatory requirements, and ethical guidelines
Act as key source of knowledge/information on understanding of the medical environment, company's & competitor's product data and unmet medical needs.
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
Strong communication and interpersonal skills to effectively collaborate with colleagues and stakeholders

Are you an experienced Cro Manager looking for a new challenge? We are looking for a motivated and organized individual to join our team and help us reach our goals. You will be responsible for managing the day-to-day operations of our Cro department, including budgeting, forecasting, and reporting. If you have a passion for problem-solving and a drive to succeed, this is the perfect opportunity for you!

Overview A Clinical Research Manager (CRM) is responsible for the management of clinical research projects. The CRM is responsible for the successful completion of clinical trials, including the development of protocols, the selection of sites, the recruitment of patients, the collection of data, and the reporting of results. The CRM is also responsible for ensuring that all clinical research activities are conducted in accordance with applicable regulations and guidelines. Detailed Job Description The Clinical Research Manager is responsible for the management of clinical research projects. The CRM is responsible for the successful completion of clinical trials, including the development of protocols, the selection of sites, the recruitment of patients, the collection of data, and the reporting of results. The CRM is also responsible for ensuring that all clinical research activities are conducted in accordance with applicable regulations and guidelines. The CRM is responsible for the development of clinical trial budgets, the management of clinical trial timelines, and the coordination of clinical trial activities. The CRM is also responsible for the management of clinical trial personnel, including the selection, training, and supervision of clinical trial staff. The CRM is also responsible for the development and implementation of quality assurance and quality control procedures. Job Skills Required
• Knowledge of clinical research regulations and guidelines
• Knowledge of clinical trial design and methodology
• Knowledge of clinical trial budgeting and timelines
• Knowledge of clinical trial data collection and analysis
• Knowledge of clinical trial personnel management
• Knowledge of quality assurance and quality control procedures
• Excellent organizational and communication skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects simultaneously
Job Qualifications
• Bachelor’s degree in a related field
• At least 5 years of experience in clinical research
• Certification in clinical research (e.g. CCRA, CCRP)
Job Knowledge
• Knowledge of clinical research regulations and guidelines
• Knowledge of clinical trial design and methodology
• Knowledge of clinical trial budgeting and timelines
• Knowledge of clinical trial data collection and analysis
• Knowledge of clinical trial personnel management
• Knowledge of quality assurance and quality control procedures
Job Experience
• At least 5 years of experience in clinical research
• Experience in the development and implementation of clinical trial protocols
• Experience in the selection and management of clinical trial sites
• Experience in the recruitment and management of clinical trial patients
• Experience in the collection and analysis