Clinical Research Coordinator or Research Assistant

Avera•Pierre, SD

11d•Onsite

About The Position

This position supports projects in maternal and child health studies at Avera Research Institute, including the ECHO study (Environmental influences on Child Health Outcomes). The ECHO study is a longitudinal, observational study following pregnant women and their children to understand how environmental exposures in the prenatal and early childhood time frame affect health outcomes for children later in life. The Clinical Research Coordinator (CRC) is an advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for the implementation of the study protocol, recruitment plan, study visits, data, study assessments, and other tasks outlined in the protocol. This position requires close collaboration with the study team and investigator to ensure safe and compliant research procedures and follow-up per the established research protocol. The CRC will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations, with opportunities for ongoing learning and contribution to research focused on improving health and wellbeing of individuals and the community. The Research Assistant (RA) works under general direction to perform professional level medical or scientific research assignments. The RA performs diverse and complex duties, with a focus on entering patient data into a variety of computer based systems, scheduling of daily activities, tracking specimens, retention and organization of documentation, and data functions for staff.

Requirements

Research Assistant: High School Diploma or GED
Clinical Research Coordinator: Bachelors from a four year college or university within the health and science field.
Ability to work the hours specified.
Visual acuity adequate to perform position duties.
Ability to communicate effectively with others.
Ability to hear, understand and distinguish speech and other sounds.

Nice To Haves

1-3 years Human Research
1-3 years Laboratory or clinical

Responsibilities

Coordinates research studies per Good Clinical Practices guidelines, FDA regulations, and approved protocols.
Understands and adheres to Standard Operating Procedures (SOPs).
Ability to develop or improve SOPs, help guides, and other team resources.
Acquires detailed knowledge of assigned research protocols and ability to conduct study required processes, procedures, and assessments.
Ability to prepare, utilize, and review Case Report Forms.
Collects and manages data, Case Report Forms, and timely entry into the electronic data capture system.
Collects and assists with processing all laboratory specimens to include centrifuging, separating, measuring, storing, shipping, and distributing to appropriate testing areas.
Maintains inventory of laboratory supplies and study kits.
Screens, recruits, and enrolls study participants using study’s eligibility criteria.
Performs the informed consent, answering all participant questions, and obtaining appropriate sign-off.
Ensures the adherence to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.
Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials.