Sub Investigator

6 days ago

Dallas, TX, United States Alliance Clinical Network Full time

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1) Comply with all company policies, procedures, and conduct.

2) Strictly adhere to confidentiality and compliance standards.

3) Review medical histories and concomitant medications of study subjects.

4) Confirm inclusion and exclusion study criteria.

5) Field subject questions related to the investigational product, study procedures and health.

6) Provide medical oversight required for medically attended events such as vaccinations and infusions.

7) Maintain GCP and study specific training requirements.

8) Oversee aspects of clinical trials as directed by the site Investigator MD.

9) Perform clinical study-related procedures.

10) Make medical judgements and other decisions on behalf of the Investigator MD.

11) Meet all study protocol requirements and deadlines.

12) Perform accurate and timely documentation in eSource.

13) Assist in answering queries and documentation in eSource.

EDUCATION and EXPERIENCE:

Advanced degree as a MD, PA-C or Nurse Practitioner, required.

Active and unrestricted license in the state of practice, required.

Prior experience in pharmaceutical research, clinical trials or academia is highly desirable.

Proficiency in research methodologies, data analysis software and statistical tools.

Strong analytical and critical thinking skills for research design and data interpretation.

Excellent written and verbal communication skills for preparing research reports and presentation of findings.

Thorough understanding of research regulations, guidelines, and standards (i.e. FDA, ICH, GCP).

Flexibility to adapt to evolving research priorities and changing project requirements.

A proven ability to multi-task in a rapidly changing environment.

Work Location - Dallas, Texas (Part Time)

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