Research Associate Clinical/Data Entry (Per Diem)

Parexel•Baltimore, MD

40d•$20 - $22•Onsite

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Title: Entry level Research Associate (per diem) Clinical/Data Entry Work Location: onsite in Baltimore, MD (some of the data entry work can be done remotely after training) Parexel Early Phase Clinical Unit supports the development of innovative new medicines which are vital for public health, improving outcomes, and saving lives. The early phase and “first in human” trials are the first step in testing these novel treatments in humans. At Parexel Baltimore, MD unit our highly trained and skilled Research Associates are crucial to ensuring the successful completion of Phase I trials. This is a great role for anyone that aspires to be an enrollment specialist, clinical research coordinator, or eventually manager. Parexel provides a great system of support to help you grow and advance your career internally. What you’ll do after training is completed (including but not limited): Clinical: You will understand study protocols and be able to complete required medical procedures. Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments. Enter study participants in the study participant tracking system Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results Prepare/monitor study supplies and stock levels in clinic/hospital. Ensure basic study participant safety is provided. Assist with Monitor visits (i.e., room set up, etc.). Maintain and update knowledge of Clinical Operating Guidelines and their proper application. Assume appropriate role with study participants and caregivers. Assure quality and accuracy of source and CRF documentation. Data Entry: Complete Case Report Forms/eCRF’s according to sponsor expectations and set documentation standards for staff to follow. Review, monitor and address quality of data entry for accuracy and trends throughout the study. Maintain neat and legible documentation across all Case Report Forms. Review Case Report Forms to confirm capture of data according to protocol and amendments. Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries. Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions. Organize track and report status of data entry to ensure that study data timelines are met. Check, review and ensure timely submission of data clarifications/queries.

Requirements

Proven customer service experience in a fast-paced environment
Background working in a medical or clinical setting
Comfortable with prolonged periods of standing and walking
B.S.+ in related life science field OR HS diploma/GED with relevant experience
First 4 to 6 weeks required to work 30 to 40 hours a week for training (day shift M-F 6:50am to 3:20pm)
Minimum availability requirements: 16 hours of availability per week AND two 12-hour weekend shifts in a 4-week month OR three 12-hour weekend shifts in a 5-week month
Seeking flexible candidate that can work any shift (day, evening, overnight, & weekend)

Nice To Haves

CPT/Phlebotomy is highly preferred

Responsibilities

Understand study protocols and be able to complete required medical procedures.
Recruit study participants by calling the database, attending company sponsored community events, posting flyers in schools, senior centers, supermarkets, and other establishments.
Enter study participants in the study participant tracking system
Conduct screening visits and study protocol specific study participant visits, assist staff physicians in assessment of concomitant medications, adverse events, lab results, and other test results
Prepare/monitor study supplies and stock levels in clinic/hospital.
Ensure basic study participant safety is provided.
Assist with Monitor visits (i.e., room set up, etc.).
Maintain and update knowledge of Clinical Operating Guidelines and their proper application.
Assume appropriate role with study participants and caregivers.
Assure quality and accuracy of source and CRF documentation.
Complete Case Report Forms/eCRF’s according to sponsor expectations and set documentation standards for staff to follow.
Review, monitor and address quality of data entry for accuracy and trends throughout the study.
Maintain neat and legible documentation across all Case Report Forms.
Review Case Report Forms to confirm capture of data according to protocol and amendments.
Work closely with Investigators, Clinical Research Coordinators and Research Associates to document, resolve and integrate data clarification/queries.
Edit, communicate/meet with Early Phase Management, Clinical Research Coordinator, Project Manager, Investigators to ensure clean data submissions.
Organize track and report status of data entry to ensure that study data timelines are met.
Check, review and ensure timely submission of data clarifications/queries.