Clinical Research Coordinator

Avera•Sioux Falls, SD

6d•Onsite

About The Position

An advanced position that contributes to the overall operations of one or more research studies. The CRC is responsible for 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. This position will work directly with research participants, physicians, nurses, community stakeholders, and health/social service organizations. This position has opportunities for ongoing learning and contribution to research that is focused on improving health and wellbeing of individuals and the community. This position may support multiple types of research projects at Avera Research Institute, including observational studies and clinical trials. Research areas may include maternal and child health, public health, clinical research, and other studies involving varied patient populations across multiple health conditions. This position may include supporting the ECHO study, Environmental influences on Child Health Outcomes, a longitudinal, observational study following pregnant women and their children to better understand how environmental exposures during the prenatal and early childhood time frame affect health outcomes for children later in life. The position may also support clinical trial activities across a variety of research areas. Responsibilities may include patient screening, recruitment and enrollment, data collection and management, study assessments, lab draws, EKGs, vital signs, study drug injections, patient education, and maintaining study records in an electronic database. The individual may also help ensure compliance with study protocols and regulatory requirements while working closely with a multidisciplinary team, including pharmacy, principal investigators, sponsors, and other research partners. We are seeking individuals who have a strong interest in working with diverse patient populations and research participants across multiple disease states and areas of research. This may include pregnant women, children, and patients participating in observational studies or clinical trials. Ideal candidates will have an interest in public health, maternal and child health, clinical research, and supporting research that advances health outcomes across a variety of populations.

Requirements

Must be able 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.
Bachelor's From a four year college or university within the health and science field.

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.
Preforms 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.