Clinical Research Coordinator II

Iterative Scopes Inc.•Dayton, OH

38d

About The Position

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 70+ clinical research sites across US and Europe 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. Job Title: Clinical Research Coordinator II Location: One GI-Dayton Reports To: Regional Director, Clinical Research Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities

Requirements

High School Diploma or equivalent required.
Three+ years previous experience in clinical research for pharmaceutical phase II or III trials required.
Clinical experience in an office or hospital setting.
Must maintain current licensure and/or certification.
Basic Life Support certification required.
Knowledge of medical terminology, anatomy, physiology, and pathophysiology.
Familiarity with health care systems, regulations, policies, and functions.
Understanding of clinical research documentation standards.
Knowledge of equipment, supplies, and materials needed for medical treatment.
Understanding of basic laboratory procedures including phlebotomy, preparation, and screening.
Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials.
Computer skills - good working knowledge of MS office.
Ability to communicate effectively with others, both verbally and in writing.
Proven ability to manage time, meet deadlines and prioritize.
Able to maintain standards and professionalism during periods of fluctuating workloads.
Provide professional service to direct customers of Impact Research in all interactions.
Build effective working relationships with other team members.
Manage daily tasks to ensure business needs are consistently met.
Provide professional service to direct customers of One GI in all interactions.
Build effective working relationships with other team members.
Manage daily tasks to ensure business needs are consistently met.

Nice To Haves

Associate or Bachelor's degree preferred.
Previous GI trials experience preferred.

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 completes 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, research team, and Regional Director with various administrative tasks associated with the day-to-day operations of research studies and projects.
Plan and coordinate with the research team and Regional Director 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 trial 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.