Physician Sub Investigator

Summary: The Physician Sub Investigator works closely with the Principal Investigator to oversee the execution of study protocols, delegating study related duties to site staff, as appropriate, and ensuring site compliance with study protocols, study-specific laboratory procedures, standards of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines, and other state and local regulations as applicable.

Essential Functions: - Performs all job responsibilities in accordance with standards of Good Clinical Practice - Delegates study responsibilities as appropriate to trained study staff - Possesses a working knowledge of GCP/ICH guidelines, Clinic SOPs, QA/QC procedures, and Investigator 1572 Form - Maintains qualifications to perform clinical research including up-to-date certification in Collaborative Institutional Training Initiative (CITI Program) training - Reviews Investigator's Brochure prior to performing any study related activities - Ensures informed consent has been obtained prior to performing any study procedures - Performs all study responsibilities in compliance with the IRB approved protocol - Reviews screening documentation and approves subjects for admission to study - Reviews admission documentation and approves subject for randomization - Interprets ECGs within agreed Sponsor timelines - Documents all findings in subject specific source documents - Provides ongoing assessment of the study subject/patient to identify Adverse Events - Ensures proper documentation and reporting of all Adverse Events and Serious Adverse Events - Reviews and evaluates all study data and comments to the clinical significance of any out of range results - Performs physical examinations as part of screening evaluation and active study conduct - Performs medical procedures within the scope of training and license, as indicated by the protocol, project specific procedure (PSP), or as clinically indicated - Present on-site pre-dose and a minimum of 2 hours post-dose, or longer if required by the protocol, PSP, or as clinically indicated. - Provides medical management of adverse events as appropriate - Completes all study documentation in accordance with the study specific requirements - Communicates with Sponsors and auditors as requested - Participates in on-call activities as required to ensure adequate medical coverage - Monitors safety and well-being of study participants at all times - Provides coverage for the Clinic Principal Investigator

Qualifications: - Education/Licensure MD or DO

with current and unrestricted medical licensure in the state of Florida is required. - Board Certification Required in a relevant specialty (e.g., Internal Medicine, Family Medicine, Emergency Medicine, Cardiology, etc). Candidates who are board-eligible or possess equivalent training and experience will also be considered. - One (1) year of clinical research experience, Phase I preferred Minimum of three (3) years working in a hospital or clinical environment - ACLS Certification

Knowledge, Skills, Abilities: -Possesses excellent organizational and time-management skills and a strong attention to detail - Possesses excellent oral, written, and interpersonal communication skills - Able to work independently and handle multiple competing priorities in a fast paced environment - Demonstrates familiarity with database design and relational databases - Knowledge of medical and research terminology and procedures and clinical data - Trained in computerized systems for clinical trials - Proficient in Microsoft Office suite - Speaks, reads, and writes English fluently

Shift Schedule: Variable, including weekends and evenings as-needed, typically 8hr duration, always coordinated before shift assignment. The hours will be variable depending on projects at the clinic and may include days for what would typically be screening assessments or admission assessments, or evenings/weekends for study-related procedures such as dosings, ECG review and interpretation, lab review and interpretation.