Principal Investigator - Medical Director

Job Description

The Principal Investigator/Medical Director conducts and coordinates daily clinical trial activities according to ICH/FDA/GCP guidelines, local regulations, study protocol, and company policies and processes. Working with a local and central team drives clinical oversight and the quality of the assigned studies at the site.

Key Responsibilities

Essential Job Duties:

• Ensures the medical well-being and safety of the study participants through the safe performance and ethical execution of the clinical trials, in adherence with FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, as well as company policies and processes
• Overall site leadership with a focus on enhancing efficiencies, patient safety and protocol/GCP /regulatory compliance
• Evaluates and assesses participants to ensure only eligible participants enroll into the trials.
• Participates and engages in successful delivery and retention of study participants.
• Interacts positively and collaboratively with sponsors, clients and team members.
• Practices attention to detail in recording data and participant information, following protocol guidelines and GCPs.
• Actively involved in protocol training for staff.
• Participate in Investigator Meetings (IMs), and continuing education activities in order to maintain current knowledge of recruitment affairs and issues.
• Perform other duties as assigned, requested, or required based on the needs of the participants, protocols and/or company.

Skills, Knowledge and Expertise

Minimum Qualifications:

• MD or DO degree, an active physician license (in good standing) in the state of practice is required.
• Experience in a medical research environment is preferred.
• Board certification in area of specialty preferred.
• Willing to conduct physical/neuro exams, reviewing I/E criteria, comfortable diagnosing, reviewing labs, reading ECGs.

Required Skills:

• Clinical skills including phlebotomy, vitals, ECGs/EKGs, IVs, etc., and clinical procedures based on area of specialty.
• Proficiency with computer applications such as MS Office, electronic health records, and web applications, and the ability to type proficiently (40+ wpm).
• Must possess strong organizational skills, attention to detail, and math proficiency.
• Well-developed written and verbal communication skills. Bi-lingual (English / Spanish) proficiency is highly preferred.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, employees, subjects, managers and external customers.
• Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
• Ability to be professional, respectful of others, self-motivated, and exemplify a strong work ethic.
• Must possess a high degree of urgency, self-motivation, integrity and dependability.
• Ability to work independently to identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.