Research Assistant

Job Summary

The Obstetrics & Gynecology Research Network has an opening for a Research Assistant/Analyst. This individual will provide support for research projects focused on high-risk pregnancies, ranging from internal chart reviews to large, industry and federally funded studies. This position involves working closely with investigators, study coordinators, clinic and research teams to carry out protocols in various areas of women's and newborn's health. This is a patient-sensitive role and requires all associated vaccination requirements, or approval for an exemption, prior to the first day of work.

Responsibilities

• Learn study protocols; assess for clarity and subject safety
• Review and understand inclusion/exclusion criteria
• Screen clinic schedules for potential study participants and healthy control participants
• Carry out study eligibility screening of patients in a clinical setting
• Recruit and consent eligible patients
• Explain the study protocol and inclusion criteria to physicians, patients, and health care providers in person and by phone; ensure participant understanding of the protocol
• Gather, record, and enter data from study participants, charts, and EMR's into study databases
• Maintain source documents, status reports, progress notes, and subject logs in accordance with FDA, HIPAA, and GCP guidelines
• Complete medical chart reviews
• Work with research teams and clinicians to meet enrollment goals and study deadlines
• Collect and process biospecimens and clinical measurements from study participants (phlebotomy training will be provided as needed)
• Assist in packaging and shipping of samples/biospecimens
• Report and track adverse events
• Document all protocol deviations, reconcile test article accountability at study close and prepare summary report for department and sponsor
• Attend team and study meetings
• Affiliate with supplies
• Work with confidential health information and complete the necessary trainings to do so
• Regulatory management and reporting
• Other duties as assigned

Team Culture

Supports a transparent and supportive work environment. Reliable, displays a positive attitude, does not engage in gossip, supports the team and is flexible. Communicates problems, issues and frustrations to supervisor and/or OB/WCSL Leadership.

Department

The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget.

Qualifications

• EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).
• Successful candidates will be independent self-starters; willing to learn study interview, research and assessment techniques; have excellent communication and organizational skills; work well with a team and be comfortable with computer databases; seeks solutions to problems; invested in creating a sustainable infrastructure to support research; seeks solutions to problems; proactive in working on various protocols; effective and appropriate communication during sensitive topics; comfortable with death and conversations surrounding it; comfortable with attending long surgeries.
• The Ideal Candidate Will Have Familiarity with clinical research and study protocols Prior experience interacting with patients in a clinical setting Experience working in women's health Phlebotomy certification Experience with biospecimen collection and processing Prior CITI, HIPAA, GCP and/or IATA training Familiarity with REDCap A background in nursing, science, or a related field