Clinical Research Assistant

Foundation for Atlanta Veterans Education and Research, Inc.•North Decatur, GA

About The Position

The Clinical Research Assistant will be responsible for identifying, recruiting, and screening potential study participants, conducting patient/family education, patient evaluations, administering medications and research instruments. This role involves collecting specimens, including phlebotomy, processing, and preparation for shipping, as well as ECG tracings and/or vital signs. The assistant will collect and document data, assist in developing data collection systems, and compile reports. They will review information from medical records to extract data for assigned research protocols, accurately capture and enter data into clinical trial databases within set timelines, and maintain complete records and metrics on each participant. The role also includes consolidating clinical data and reports for investigators, providing support during monitoring and auditing preparation, and ensuring compliance with research and healthcare regulatory requirements. Performing related responsibilities as needed is also part of the role.

Requirements

High school or GED is required.
1 year of experience in a research-related role.
High level of attention to detail and good organizational skills.
Strong written and verbal communication skills.
High level of use and comfort with MS Office products, data management systems, and the Java and/or Python programming languages.
Friendly and people-oriented to ensure that the veteran population is engaged in a positive experience.
Ability to achieve/exceed time-bound goals in both an independent and team environment.

Nice To Haves

Bachelor's or Master's degree in science, public health, business or computer science is preferred.
Experience in performing research-related study activities is beneficial for a successful incumbent.
These could include regulatory affairs, study procedures, phlebotomy certification, processing/shipping biological specimens, and database management.
Certified Research Associate (CRA) or Clinical Research Coordinator (CRC) preferred.

Responsibilities

Identifies, recruits and screens potential study participants, and conducts patient / family education. patient evaluations, administers medications and research instruments.
Collects specimen, to include phlebotomy, processing and preparation for shipping, ECG tracings and/or vital signs.
Collects and documents data, assisting in developing data collection systems and compiling reports.
Reviews information from medical records to extract data for all assigned research protocols.
Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by site lead or study sponsor.
Collects and maintains complete records and metrics on each research study participant. Consolidates clinical data and reports for investigators as needed.
Provides support during internal and external monitoring and auditing (e.g., sponsor, regulatory agencies) preparation, including supporting data deficiency corrections and development of corrective action plans post audit.
Ensuring compliance with research and health care regulatory requirements and guidelines.
Performing related responsibilities as needed.
Managing patient participation in a research study and/or clinical trial, not limited to recruitment, screening, education and evaluations.
Supporting and assisting in all aspects of clinical data management, protocol data management, including creation and collection of source documents, completion of case report forms, and tracking / reporting of serious adverse events.
Collaborating with the principal investigators, study coordinators, and other study personnel regarding study planning, implementation, and evaluation efforts.