The Research Assistant supports clinical trial activities by assisting the study team with recruitment, screening, and protocol management. They are also responsible for maintaining study documentation, managing supplies, and ensuring compliance with regulatory and site policies.
Requirements summary
Candidates must have a high school diploma or equivalent and at least 2 years of experience in a healthcare setting. Strong written and verbal communication skills and the ability to interpret research protocols are required.
high schoolCommunicationDocumentationProblem solvingInventory managementRegulatory complianceData entrySpecimen processingClinical researchHealthcare administrationPatient recruitmentGood clinical practiceProtocol managementClinical trial management systemPatient welfareInclusion and exclusion criteria
Job description
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Research assistant
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, on-site Research Assistant (RA). The RA is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) and site management. The primary responsibility of the RA is to assist the Clinical Research Coordinators with conduct of research studies. The RA supports and facilitates the daily clinical trial activities and plays a supportive role in the conduct of the study.
Responsibilities
Assists Study Team with communicating study requirements to all individuals involved in the study
Works with the Study Team to develop and implement recruitment strategies in accordance with site policies and IRB requirements and approvals
Assists Study Team with screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
Assists Study Team as requested to register participants in the Clinical Trial Management System to ensure billing of study procedures to appropriate funding source
Maintains inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or site policies on Investigational Drug/Device Accountability
Assists Study Team in completing study documentation and maintenance of study files in accordance with sponsor requirements and site policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms
Aids the Study Team in maintaining effective and ongoing communication with sponsor, research participants, site management and PI during the course of the study
Works with the Study Team to manage the day to day activities of the study including problem solving, communication and protocol management
Collects and reports ongoing patient recruitment/ enrollment progress and metrics to site management and PI
As directed, process and ship specimens per study protocol and IATA regulations
Arranges secure storage of study documents that will be maintained according to Good Clinical Practice guidelines or for the contracted length of time, whichever is longer
Enter all patient visit data in e-CRF and CTMS on a daily basis or as directed
Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
Other duties as assigned
Iterative Health Expectations
All employees are expected to
Perform quality work within deadlines with or without direct supervision
Interact professionally with other employees, customers and suppliers
Work effectively as a team contributor on all assignments
Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
High school diploma or equivalent. Some college preferred
Minimum 2 years in a healthcare setting
Strong written and verbal communication skils
Ability to read, interpret, and apply clinic policies and research protocols
Ability to use standard office software
Must be able to lift up to 25 pounds
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
