Neurologist Principal Investigator
Pinnacle Clinical Research- A Summit Solution · San Antonio, TX · 2 wk ago
On-siteHealthcareInternship
About the role
The Clinical Research Physician Investigator or PI is responsible for administering activities to facilitate clinical research and providing clinical support for the conduct and oversight of clinical trials. The PI agrees to assume the overall responsibility for the study conduct.
Responsibilities
- Review and hold expert knowledge of study-related activities and protocols
- Assume all responsibilities and obligations as an Investigator, per Title 21 part 312 and FDA Form 1572
- Adhere to study protocols, FDA regulations, and Good Clinical Practice (GCP) at all times
- Maintain study sponsor and clinical trial confidentiality
- Perform study-related procedures such as physical examinations, informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessments
- Review and adjudicate all lab, imaging, and biopsy findings
- Assist in the preparation of study monitor visits
- Perform subject screening and recruitment
- Provide some weekend coverage to facilitate study visits per protocol
- Provide after-hours phone call coverage as needed
- Oversee Sub-Investigators and recruitment team
- Personally conduct or supervise the research
- Ensure that everyone to whom a task is delegated is qualified by virtue of education, training, and experience to perform each of their delegated tasks
- Protect the rights, safety, and welfare of the participants who will be under their care
- Ensure the research is conducted in accordance with all federal regulatory requirements, state law, and Pinnacle Clinical Research policies (including SOPs)
- Ensure the research is conducted in accordance with the IRB-approved plan
- Ensure the accuracy, security, and integrity of the research data and the subsequent analysis of that data
Qualifications
- Current physician license
- Board Certified preferred
- One to two years of research experience as a principal investigator preferred
- At least one to two years of clinical practice in Neurology Alzheimer Disease research experience highly preferred
Skills
- Written and oral communication skills
- Bilingual (English and Spanish) strongly preferred
- Organizational skills
- Ability to pay attention to detail
- People skills including possessing a positive, friendly, and professional demeanor
- Ability to be flexible with changing priorities
- Ability to communicate in a diplomatic and professional manner
- Strong interpersonal skills
- Strong mathematical knowledge
- Excellent computer skills including knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Firefox, and web-based enterprise solutions software
Work environment
- Work is performed in an office/laboratory and/or a clinical environment
- Exposure to biological fluids and/or bloodborne pathogens
- Personal protective equipment is required such as protective eyewear, garments, and gloves
- Occasional travel may be required domestic and/or international
- Ability to work in an upright and/or stationary position for 6-10 hours per day
- Frequent mobility required
- Occasional squatting, kneeling, or bending
- Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs