Education and Technical Skills:
- Medical Doctor (MD) or Doctor of Osteopathy (DO), prior research experience preferred
- Active, valid State of Florida Medical License is required
- Have current certification in CPR or be willing to obtain certification
- Proficient with Microsoft Office Suite and other general computer software and function
Qualifications:
- Knowledge of medical terminology, drug calculations, clinical medicine, clinical trials and standards of Good Clinical Practice (GCP)
- Knowledge of federal, state, and local regulations, including HIPAA policies and procedures
- Self-directed and able to work without direct supervision
- Excellent written and verbal communication skills
- Professional demeanor, strong customer service skills with the subjects and their family members
- Enjoy working with a diverse group of people (co-workers and patients alike) with an ability to listen and provide empathy when needed
- Ability to maintain an organized workspace and office environment
- Detail-oriented, ability to proactively identify and correct errors
- Ability to plan ahead, multitask, prioritize, and manage time efficiently
- Ability to work in a team setting as well as independently
Essential Job Functions:
- Interpret medical test results as required by the study protocol; these include, but are not limited to vital signs, clinical laboratory testing, electrocardiograms, urine pregnancy tests, mycology collection and resulting as well as performing punch biopsies
- Performs medical assessments as required by the study protocol; these include, but are not limited to physical examinations, indication assessments as well as collecting current and prior medical history, medications and treatments
- Reads and understands all the information in the study protocol, the investigator’s brochure, the informed consent, and study Source documents
- Provide patient education and medical information to study subjects to ensure understanding proper investigational product medication dosage, administration, treatment as well as potential risks and side effects
- Ensures compliance with each study protocol by providing thorough review and documentation of all medical and research data in the subject chart for each subject visit to capture all protocol required elements
- Collaborates with research staff to ensure all data elements are attributable, legible, contemporaneous, original, accurate and are reviewed prior to the end of shift to ensure completeness
- Identifies and documents adverse events, serious adverse events and protocol deviations; collaborates with the research staff to ensure proper documentation, reporting and subject follow-up
- Monitors the safety and welfare of the participants in the trial.
- Assists with the completion all of required reports (i.e., adverse events, protocol deviations, pregnancy reports, safety reports, IRB Reports in an accurate and timely fashion
- Participates in the informed consent process with each subject during the Screening visit and then throughout the study
- Ensures subjects eligibility prior to randomization
- Ensures communication with sponsor and sponsor representatives is conducted professionally
- Contributes to the site level recruitment strategy; evaluates recruitment needs to meet study enrollment goals
- Schedules and participates in company sponsored community events for the purposes of company promotion, name recognition and study recruitment
- Evaluates MCR employees for minor illnesses; recommend treatments
- Prepares for and participate in corporate, sponsor, and/or FDA audits
- Participates in and provide continuing clinical education for self and research staff
- Help in maintaining a clean, professional work environment
- Supports and conducts behaviors commensurate MCR Employee Standards
Working Conditions and Physical Demands:
- Professional medical office; inside, busy environment with many potential interruptions and distractions
- Multiple tasks must be performed simultaneously and within deadline
- Potential for exposure to blood and body fluids during laboratory testing
- Potential for exposure to hazardous materials (e.g., cleaning agents and solutions)
- Required to sit and/or stand for extended periods of time, use of hands and fingers in fine manipulation of office and medical equipment, use of telephone, talk, listen
- Reaching, standing, stooping, kneeling, crouching and lifting up to 15 pounds
- Travel must be performed between offices and/or business locations
- Continuing education and job-related training is required annually
- Local and out-of-state travel is required
Licenses & Certifications
Required- Medical Doctor
Skills
Required- Medical knowledge
- Making decision
- Critical Thinking