Data Entry Administrative Assistant

Raquel E. Hartman

** ******** ********, ********* ** 14617

585-***-**** / ************@*****.***

Experience:

November 2020- 02MARCH2022 Study Coordinator, URMC Gynecology Oncology

a.Assists in recruitment activities and in screening potential study participants for eligibility

b.Supports participant recruitment and retention strategies and follow-ups, maintaining contact with subjects between visits and using study visit reminders (as per protocol)

c.Performs study procedures, routine tests, data collection/recording, and “day-to-day” operations of moderate risk clinical research protocols

d.Maintains all logs, including entry into OnCore, our clinical trials management system, according to University and department SOPs

e.Maintains study binders and filing according to protocol requirements and University and department policy

f.Enters data accurately; helps manage/organize case report forms, source documents, and study databases

g.Distributes study drug//materials according to practice standards, clinical credentials and as delegated by the Investigator

h.Monitors, documents, reports, and follows up on study unanticipated/adverse events and protocol deviations

i.Schedules and participates in Site Initiation Visits (SIV) and monitoring visits and participates in research team and Principal Investigator oversight meetings as required

j.Schedules and prioritizes study visits/procedures/clinical tests in synchrony with data collection activities according to established time-points; tracks progress of participants through protocol as well as overall study progression of the protocol

k.Assists in problem solving logistical challenges to assure study objectives are achieved according to protocol and projected time-line

l.Study visit preparations – keep research tabs updated and calendar invites

SEPTEMBER 2016-November 2020 Research Assistant, Rochester Clinical Research

a. Preparation of study charts based on a template prepared by the Study Coordinator

b. Accurate and timely data entry

c. Ensuring charts are prepped for the next day including lab kit preparation

d. Filing in both study charts and study files

e. Completing study logs as assigned

f. Completing follow up phone calls as assigned

g. Working with the Administrative Assistant to ensure Primary Care Physician letters are completed at the beginning and end of the trial

h. Prepare for monitor visits

i. Assist monitors

j. Update logs and statistics in Clinical Conductor

k. Collapse and archive completed charts

l. Perform vitals, EKG’s and other study procedures as directed by Study Coordinator eg. spirometry, vibratron

m. Other tasks as delegated

2. Keep all study lab kits organized and in stock- notify lab technician of any supply needs based on visit schedules

3. Support other RA’s in data entry/chart prep/support their Study Coordinators as needed

4. Organize archived studies periodically and update master list

5. Locate old records as needed

6. Complete weekly QA EDC crosschecks and other QA projects as assigned by QA Director.

7. Assist lab for phlebotomy, processing, and shipping as needed

8. Perform free screen visit procedures-ICF, collect samples and vitals, present to clinical staff for review.

9. Assist on assigned device trials with oversight by the Director of Clinical Operations

a. Follow the research protocol directly and adhere to good clinical practices

b. Conduct Study Visits as approved by PI and Director of Clinical Operations

c. Administer Informed Consent to subjects according to the RCR SOP’s

d. Review Inclusion/Exclusion criteria per protocol with subject and Investigator

10. Additional duties as assigned by Director of Clinical Operations and noted on the delegation log.

2011-June 2015 Outpatient Access Specialist, University of Rochester- Pediatric Gastroenterology and Nutrition

a. Multi tasking, problem solving, excellent customer service, organization skills, leadership skills

b. Insurance authorizations (medications, formulas, treatments, admissions, 2nd opinions)

c. Scheduling appointments, knowledge of computers and computer systems (medical systems)

EDUCATION:

2007- West Irondequoit High School Graduate

2014-2015 - Some college: MCC, Bryant and Stratton

References:

1.)Antonia Muratore- Billing specialist at the University of Rochester: 585-***-****

2.)Julie Mooney, RN- Senior Study Coordinator at Rochester Clinical Research: 585-***-**** [ask for Julie]

3.)Kathleen Ebeling- Senior Study Coordinator at Rochester Clinical Research: 585-***-**** [ask for Kathleen]

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