THE ROLE:

1. Develops and tracks work flow policies and progress through the duration of the research study or clinical trial. Assists Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
2. Oversees subject enrollment to ensure that informed consent is properly secured and documented.
3. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with research personnel.
4. Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educates and trains personnel on compliance and protocol.
5. Identifies protocol problems, informs investigators, and assists in problem resolution efforts.
6. Manages complex study or trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data.
7. Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports.
8. Reviews proposed study protocols to evaluate factors such as sample collection process, data management plans, and potential subject risks. Conducts quality assurance audits on data and regulatory documentation.
9. Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
10. Assists in budget development, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.

Must Haves:

• have excellent interpersonal, communication, and customer service skills while working with patients.
• are a go-getter who does well multi-tasking.
• have received your Bachelor's degree.
• and have 2 years of clinical research experience.

* Get an amazing opportunity to grow in a smaller team.

* Work on innovative, cutting-edge GI trials.

* Have the ability to work a hybrid schedule. At least 1 day working from home per week.

* Monday - Friday 8a-4p