APRN/Sub-Investigator

The APRN/Sub-Investigator is responsible for performing critical trial-related procedures and/or making important trial-related decisions, under the supervision of the Principal Investigator. Oversees the execution of study protocols, ensuring Site compliance with protocols and study-specific Laboratory procedures. All duties are carried out in accordance with the Site’s SOPs, Good Clinical Practices (GCP), HIPAA, International Conference of Harmonization (ICH) and OSHA guidelines, and all applicable Local, State, and Federal regulations.

Job functions:

• Review the Investigator’s Brochure and study protocol before performing any study-related activities.
• Ensures informed consent has been obtained before 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 subject documentation and approves subject for randomization.
• Documents all findings in subject-specific source documents.
• Performs ongoing assessments of the study subject to identify, properly document, and report any Adverse Event.
• Reviews and evaluates all study data and comments on the clinical significance of any out-of-range results.
• Performs physical examinations as part of screening evaluation and active study conduct.
• 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 to study participants and protocol-related procedures.
• Monitors the safety and well-being of study participants.
• Monitors the effectiveness of interventions.
• Provides coverage for the Site’s Principal Investigator.
• Completes additional tasks as required by a specific protocol.
• This position reports to the Principal Investigator.

Desired qualifications:

• Works well in a team environment.
• Understanding of the clinical research process is preferred.
• Excellent written and verbal communication skills.
• High attention to detail and organization.
• Strong knowledge of the clinical research process, including Regulatory requirements, Good Clinical Practices (GCP), HIPAA, and International Conference of Harmonization (ICH) guidelines.
• Ability to time manage to meet Sponsors’ strict timelines and requests.
• Bi-lingual English/Spanish required.
• Ability to work after hours and weekends if needed.
• Knowledge of Microsoft Office 365

Minimum requirements:

• Current Medical license from the State of Florida (Clear active ME or APRN)
• Current provider card in Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) is preferred.

Work schedule:

• Monday to Friday – 8:00 am – 4:30 pm, unless otherwise indicated.
• Work Remotely: No

Benefits:

• Health Insurance
• 401(k) & 401(k) matching plan
• Dental & Vision
• Short & Long term disability
• Life insurance
• Paid time off
• Paid vacations
• Paid holidays
• Referral program
• Training/Professional development

Indago Research and Health Center Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of and will not be discriminated against based on race, color, religion, national origin, age, sex, gender identity, sexual orientation, genetic information, ancestry, military service, or other status protected by state or federal law. Additionally, we are committed to providing access and reasonable accommodation in its services, activities, programs, and employment opportunities in accordance with the Americans with Disabilities Act and other applicable laws