Principal Investigator: Internal Medicine

3 weeks ago

Ormond Beach, United States Alcanza Clinical Research Full time

Principal Investigator: Internal Medicine

Department: Operations

Employment Type: Full Time

Location: Accel Research Sites - Ormond, FL

Reporting To: Jennifer McCaffrey

Description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, and TX. 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.

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.

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 for this role, and a minimum of 2 years of experience in a medical research environment, or an equivalent combination of education and experience, is required. Board certification in area of specialty preferred. CPR required / ACLS preferred.

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.

Benefits

* Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
* 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.

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