About the Role
The Principal Investigator 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.
Responsibilities
- Ensures the medical well-being and safety of study participants through the safe performance and ethical execution of clinical trials, adhering to FDA, ICH, NIH, GCPs & HIPAA guidelines, study protocols, and company policies.
- Provides overall site leadership focused on enhancing efficiencies, patient safety, and protocol/GCP/regulatory compliance.
- Evaluates and assesses participants to ensure only eligible individuals enroll in trials.
- Participates and engages in the 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.
- Participates in Investigator Meetings (IMs) and continuing education to maintain current knowledge.
- Performs other duties as assigned, requested, or required based on participant, protocol, and/or company needs.
Requirements
- MD or DO degree required.
- Active physician license (in good standing) in the state of practice is required.
- Board certification in area of specialty is required.
- Experience in clinical research is preferred.
- Proficiency with computer applications such as MS Office, electronic health records, and web applications.
- Ability to type proficiently (40+ wpm).
- Strong organizational skills, attention to detail, and math proficiency.
- Well-developed written and verbal communication skills.
- Well-developed interpersonal and listening skills.
- Ability to work well independently and with others.
- Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities.
- Ability to be professional, respectful, self-motivated, and exemplify a strong work ethic.
- 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 confidentially and professionally, in compliance with HIPAA guidelines.
Skills
- Clinical skills and clinical procedures based in area of specialty.
- Bi-lingual (English / Spanish) proficiency is highly preferred.
Location
- Woodstock, GA
Work Type
- Full Time
Experience Level
- Experience in clinical research is preferred.
Education Level
- MD or DO degree
- Board certification in area of specialty
Benefits
- Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.
- Coverage starts on the first day of the month following date of hire for full-time employees working at least 30 hours per week.
About the Company
- Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico.
- We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine.
- Join us as we continue to grow.
