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Physician Sub Investigator
✦ New
Salary not disclosed
Miramar, FL 1 day ago

Core Essential Skills:

a) ACLS certified.

b) ABIM board certified (and verified) in internal medicine (and may be subspecialized as well).

c) Experience in clinical medicine which may include hospital-based or clinic-based practices, for at least one year after their terminal training.

d) Clean DEA registration and unrestricted license to practice medicine in Florida.

e) MD with board certification in internal medicine, active FL medical license, unrestricted license


Job 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 ClinicalPractice
  • 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 toperform clinical research including up-to-date certification in Collaborative Institutional Training Initiative (CITI Program) training
  • Reviews Investigator's Brochureprior to performing any study relatedactivities
  • Ensures informed consenthas been obtainedprior to performing any study procedures
  • Performs all study responsibilities in compliance with the IRB approved protocol
  • Reviews screening documentation and approves subjectsfor admission to study
  • Reviews admission documentation and approves subjectfor randomization
  • Interprets ECGs withinagreed Sponsor timelines
  • Documents all findingsin subject specificsource documents
  • Provides ongoing assessment of the study subject/patient to identify AdverseEvents
  • Ensures proper documentation and reporting ofall Adverse Events and Serious Adverse Events
  • Reviews and evaluates all study data and comments tothe clinical significance of any out of range results
  • Performs physical examinations as part ofscreening evaluation andactive study conduct
  • Performs medical procedures within the scope of training andlicense, 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 medicalmanagement of adverseevents as appropriate
  • Completes all study documentation in accordance with the study specific requirements
  • Communicates with Sponsorsand auditors as requested
  • Participates in on-callactivities as requiredto ensure adequatemedical coverage
  • Monitors safety and well-being of study participants at all times
  • Provides coverage for the ClinicPrincipal Investigator

Qualifications:

Education/Licensure MD or DO with current and unrestricted medicallicensure 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.

Experience

  • One (1) year of clinical researchexperience, Phase I preferred

Minimum of three (3) years workingin a hospital or clinicalenvironment

Certification ACLS Certification


An equivalent combination of education and experience may be acceptedas a satisfactory substitute for the specific education and experience listed above.Knowledge, Skills, Abilities (Other pertinent qualifications/skills/knowledge necessary to perform the essential functions of the job)

  • Possesses excellent organizational andtime-management skills anda strong attention to detail
  • Possesses excellentoral, written, and interpersonal communication skills
  • Able to work independently and handle multiple competing priorities in a fast paced environment
  • Demonstrates familiarity with database designand relational databases
  • Knowledge of medicaland research terminology and procedures and clinical data
  • Trained in computerized systems for clinicaltrials
  • Proficient in MicrosoftOffice suite
Not Specified
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