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Iterative Health · 5 days ago

Clinical Research Coordinator

New Albany, IN

Full-time

Onsite

Entry Level

1+ years exp

Iterative Health is a healthcare technology and services company focused on transforming patient outcomes through clinical research. The Clinical Research Coordinator will be responsible for coordinating and administering research study activities, ensuring compliance with regulatory standards and good clinical practices, while facilitating clinical trials and patient recruitment.

Health CareInformation Technology

Responsibilities

Administratively and clinically manage industry sponsored clinical trials

Adhere to Research SOP’s, Good Clinical Practices, and the study protocols

Assist in patient recruitment by performing detailed chart reviews and patient interviews

Discuss study protocols with patients and verify the informed consent documentation

Review medical history of patients against inclusion/exclusion criteria of studies

Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations

Schedule all patient research visits and procedures consistent with protocol requirements

Dispense study medication, collect vital signs, and perform ECGs

Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol

Complete and maintain case report forms per FDA guidelines and review them against the patient’s medical record for completeness and accuracy

Function in a clinical role by conducting clinical research studies

Monitor patients and provide information to the medical staff and other staff members to assure optimal outcomes

Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients

Maintain compliance of protocols and regulatory guidelines for studies performed in the research area

Act as a resource for other staff members regarding investigational issues or guidelines

Coordinate the availability and distribution of medications for patients in a timely manner

Perform phlebotomy for lab work as required and complete all necessary forms

Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved

Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures

Assist the principal investigator and research manager with various administrative tasks associated with the day-to-day operations of research studies and projects

Plan and coordinate with the research manager the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity

Plan, implement, and maintain data collection and analysis systems in support of the research protocol

Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies

Facilitate assigned clinical trials from start to finish

Screen participants for all studies independently

Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research

Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required

Adhere to infection control/safety guidelines and confidentiality policies

Qualification

Clinical research experienceClinical Practices (GCP)Basic Life Support certificationPhlebotomyMedical terminology knowledgeRegulatory compliance knowledgeOrganizedTeam workingProblem solvingCustomer focus