Clinical Research Data

TS / TEMI SODEINDE

E: ****************@*****.*** 908-***-**** A: Roselle, NJ

PROFESSIONAL SUMMARY

Inventive and versatile Clinical Research Associate/Site Manager. Documented success in managing various clinical trials, including phase I-III clinical trials in Medical device, Excellent knowledge of ICH and GCP.

THERAPEUTIC AREA OF EXPERIENCE

Medical Device :

Vacutainer plasma preparation tubes (PPT™) Blood Collection Tubes.

Plasma preparation tubes in Evaluation of HIV-1 Assays

Oncology : Colon Cancer, Solid Tumor And Breast Cancer

Central Nervous System (CNS) : Alzheimer’s, Major Depressive Disorder, Post Traumatic Stress.

WORK HISTORY

Becton Dickenson – Clinical Research Associate

Franklin Lake, Nj

09/2020 - Current

Monitors clinical studies of investigational and approved products remotely and through on-site visits

Conducts qualification, initiation, interim monitoring, and close out site visits

Acts as primary liaison between the study site staff and Concept

Monitors studies by reviewing and reporting on the following: site recruitment efforts, enrollment and subject status, findings at monitoring visits, protocol deviations/exceptions, serious adverse events and laboratory abnormalities

Reviews source data and case report forms for accuracy, completeness, and integrity of the data, and identifies and resolves ongoing data issues

Experienced using Veeva vault and Meditate Rave to upload data documents and also retrieve data, reports or template to complete projects

Meets with the Principal Investigator at the end of the visit to provide any updates and discuss findings and concerns

Processes or oversees transmission of study data according to protocol-specified timelines

Reviews data queries and listings and working with the study site staff to resolve data discrepancies

Oversees the study site staff to assess protocol compliance and appropriate data collection including proper handling, storage and shipment of biological samples or imaging scans

SKILLS

Excellent knowledge of ICH and GCP

Excellent verbal and written skills

Capable of interacting with all levels of management, coworkers, principal investigators, sub’ Investigators, Site staffs and subjects.

Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writing

Ability to independently set and manage multiple priorities

Demonstrated advanced judgment and decision making ability in the execution / oversight of clinical studies

Ability to travel up to 75% of the time

EDUCATION

New Jersey City University

Jersey City, NJ

Bachelor of Science:

Psychology

TECHNOLOGY

eCRF: Clindex, Medrio and Inform

CTMS: sFTP. Medidata Rave, Impact

TMF: Veeva Vault

Penn Medicine Princeton Health - Clinical Research Coordinator

Plainsboro, NJ

01/2018 – 09/2020

Assisted trial Investigator in screening and review of potential study participant’s eligibility.

Maintained case reports forms, charts and documentation.

Ensured that all clinical activities were carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.

Collected and entered data as necessary.

Performed miscellaneous job-related duties as assigned.

Lead in the recruitment of study subjects.

Aided in assessing eligibility of patients for participation in protocols.

Participated in the administration of informed consent process.

Responsible for the collection, entering, maintenance of data.

Reviewed data and progress notes with CRCs and principal investigator.

Prepared study files for data.

Prepared lab kits for upcoming research visits.

Processed blood and urine samples for shipping.

Performed back-up study coordination if needed by trial schedule.

A-plus Care – Program Coordinator

Brunswick, NJ

01/2017 – 01/2018

Supervised staff as specified in each client’s individual support plan to strongly execute training programs

Offered resourceful problem solving, both internally and externally, while developing and maintaining strong

client relationships

Handled follow-up telephone calls, clerical support, data entry and maintained client database

Scheduled appointments/meetings and made necessary arrangements for meetings as required

Performed research for special planning.

Monitor and schedule house and vehicle projects as assigned and prepared presentation material

Complete staff evaluations.

Monitor and maintain residential budget and overtime.

Monitor and schedule required staff training's, seminars, and conferences.

Monitor fiscal, medical, personal and ISP documentation to ensure accuracy.

Participate in Circle(s) of Support for personal future maintenance.

Oversee the maintaining and monitoring of individuals' finances.

Build a support network between the individuals and community members.

Prepare progress reports for consumer's immediate support group.

Ensure consistent service delivery that connects work, home, and recreational needs.

Submit monthly written reports to the appropriate individuals outlining operational status, progress, and concerns.

May perform the duties of Direct Support Professional as necessary, in accordance with current staffing needs.

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