Cardiovascular Clinical Research Coordinator

San Diego Cardiac Center Medical Group Inc•San Diego, CA

2d•$37 - $45•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 promotes the ethical conduct of research and facilitates and coordinates the daily clinical trial activities, playing a critical role in the conduct of the study. The coordinator schedules research subject appointments and serves as the patient liaison to the PI and other participating physicians. They review and comprehend each assigned protocol, including study proceedings and timelines, inclusion and exclusion criteria, and confidentiality and privacy protections. Working closely with the PI, the coordinator participates in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment, possessing a thorough knowledge of the informed consent process and study protocol(s) to answer all questions. The role involves coordinating and attending site initiation visits (SIV), monitor visits, and study termination visits. The coordinator completes case report forms and extracts data from research subject charts in a timely manner, and coordinates the completion of all protocol-required forms by the investigator during study visits. They respond to data clarification requests promptly and may attend investigator meetings to report pertinent information back to research team members. The coordinator collaborates with investigators to ensure clinical research activities comply with federal regulations and sponsoring agency policies. They assist the PI in developing training materials for study personnel and maintain records of training. The role includes maintaining weekly subject screening logs and promptly reporting protocol deviations to the sponsor/regulatory coordinator(s), assessing if deviations meet IRB requirements for reportable information. The coordinator manages monitoring and auditing visits, notifying appropriate officials of external audits and collaborating with the institution to respond to audit findings. They cooperate with sponsors on compliance efforts related to human research participant protection and report instances of noncompliance. The position requires proper documentation of study visit tasks in research notes, ensuring all materials for clinical trial protocols are available for subject enrollment. Collaboration with the clinical research team and support staff is essential for timely documentation and submission of study data. The coordinator assists with study materials such as informed consent documents, CRFs, enrollment logs, and drug/device accountability logs. They establish and organize study files, source documentation, and other required materials. The role also involves assisting the Principal Investigator in submitting accurate and timely closeout documents to federal agencies, sponsors, and the sponsoring agency. Secure storage of study documents is maintained according to institutional policy or contracted length of time. The position may perform other job-related duties as requested or required. The ability to perform intramuscular injections, venipuncture, peripheral intravenous lines, collect biological specimens, and administer medications via all routes is necessary. Use of standard patient care equipment and knowledge of medications, indications, dosage ranges, side effects, and potential toxicity are also required.

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.
GCP (Good Clinical Practice) Certification within the last two years (preferred).
IATA Dangerous Goods Certificate within last two years (preferred).

Nice To Haves

Cardiac Research experience is preferred, but not a requirement.
Cardiac Nursing experience is preferred, but not a requirement.

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.
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.