Cardiovascular Clinical Research Coordinator

San Diego Cardiac Center Medical Group•San Diego, CA

23h•Onsite

About The Position

The position of Cardiovascular Clinical Research Coordinator facilitates all implementation phases of new studies as well as the ongoing coordination and maintenance of open and closed studies. This role plays a critical part in the ethical conduct of research by facilitating and coordinating daily clinical trial activities. The coordinator will serve as the patient liaison to the Principal Investigator (PI) and other physicians, scheduling research subject appointments and ensuring clear communication about protocols. A thorough understanding of the study protocol, including inclusion/exclusion criteria, confidentiality, and the informed consent process, is essential. The role involves coordinating site initiation visits, monitor visits, and study termination visits, as well as completing case report forms and extracting data from subject charts in a timely manner. The coordinator will also be responsible for ensuring all protocol-required forms are completed by the investigator, responding to data clarification requests, and potentially attending investigator meetings. Collaboration with the PI and institution is key to ensuring compliance with federal regulations and sponsoring agency policies, including assisting in training development and maintaining training records. The position requires maintaining weekly subject screening logs, promptly reporting protocol deviations, and coordinating monitoring and auditing visits. The coordinator must notify appropriate officials of external audits and collaborate on responses and recommendations. They will also cooperate with sponsors on compliance efforts and document study visit tasks through research notes. Ensuring all necessary materials for clinical trial protocols are available for subject enrollment and working collaboratively with the research team and support staff are crucial. Assisting with study materials like informed consent documents, CRFs, enrollment logs, and drug/device accountability logs, as well as establishing and organizing study files, is part of the role. The coordinator will assist the PI in submitting accurate and timely closeout documents and arranging secure storage of study documents. The position may also involve performing intramuscular injections, venipuncture, peripheral intravenous lines, collecting biological specimens, and administering medications via all routes, using standard patient care equipment, and possessing knowledge of medications, indications, dosage ranges, side effects, and potential toxicity.

Requirements

Active State of California Nursing License (RN); Preferred
Active State of California Licensed Vocation Nurse (LVN); Preferred
Associate or Bachelor degree (Required)
License must be free from any disciplinary actions.
Two years' experience in a clinical research setting (preferred), working as a coordinator on Industry-Sponsored clinical trials.
Six months or more of active nursing experience.
Annual TB/Immunization Clearance required for Hospital Badge.
Documentation of current, negative TB (Tuberculosis) Test within past three months OR documentation of negative chest x-ray within six months (if individual has a positive history).
Badge Immunization Requirements include the following. Proof of Influenza Immunization during Flu Season (November – March) and/or declination form.
Proof of two doses for the following Immunizations: Measles, Mumps, Rubella and Varicella (OR) positive titers.
Proof of Tdap Immunization given within the last ten years.
Proof of at least one dose of any COVID-19 immunization series.

Nice To Haves

Cardiac Research experience is preferred, but not a requirement.
Cardiac Nursing experience is preferred, but not a requirement.
GCP (Good Clinical Practice) Certification within the last two years (preferred).
IATA Dangerous Goods Certificate within last two years (preferred).

Responsibilities

Promotes the ethical conduct of research.
Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Schedules research subject appointments and serves as the patient liaison to the PI and other participating physicians.
Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.
Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) to be able to answer all questions pertaining to the study posed during the informed consent process.
Coordinates and attends (SIV) site initiation visits, monitor visits, study termination visits.
Completes case report forms in timely manner.
Extracts data from research subject charts in a timely manner.
Coordinates the completion of all protocol required forms by the investigator during study visits.
Responds to data clarification requests in a timely manner.
May attend investigator meetings in person or remote and report pertinent information back to research team members.
Coordinates with investigators to help ensure that clinical research and related activities are performed in accordance with Federal regulations, sponsoring agency policies and procedures.
Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around tasks related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.
Maintains records and other documentation of training.
Maintains weekly subject screening logs.
Promptly report protocol deviations to sponsor/regulatory coordinator(s).
Assess whether protocol deviations meet IRB requirements for promptly reportable information with regulatory coordinator(s).
Coordinates and facilitates monitoring and auditing visits.
Notifies appropriate institutional officials of external audits by IRB's, Regulatory agencies, CRO's and sponsors.
Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations.
Cooperates with sponsor on compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
Properly documents study visit tasks in the form of a research note.
Ensures that all materials for each clinical trial protocol are available for subject enrollment.
Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
Establishes and organizes study files, study specific source documentation and other materials as required.
Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, sponsors, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.
Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
May perform other job-related duties as requested or required.
Ability to perform intramuscular injections, venipuncture, peripheral intravenous lines, collect biological specimens and administer medications via all routes.
Use of standard patient care equipment such as 12-lead ECG, pulse oximeter, blood pressure monitor, thermometer, IV pumps, & centrifuge.
Knowledge of medications, indications, dosage ranges, side effects, and potential toxicity.