Summary
This role is responsible for coordinating and managing clinical research protocols under the authority of the Principal Investigator (PI) while ensuring compliance with all institutional and regulatory guidelines. It supports Ark management and patient recruitment teams in developing growth strategies, expanding into new therapeutic areas, conducting physician outreach, and supporting site acquisition efforts. The position serves as a key liaison between investigators, sponsors, the Institutional Review Board (IRB), and patients to facilitate smooth and effective study operations. It involves ongoing evaluation of research activities, implementing protocol-guided changes as necessary, and maintaining accurate regulatory documentation. Additionally, the role leads the clinical team to ensure subject safety, timely and accurate reporting of medical tests to the PI, and the successful execution of research trials.

Duties

Train and manage research staff on study related activities and ensure research staff follow GCP and ICH guidelines
Review standard operating procedures (SOPs) and ensure research coordinators adhere to company policies and procedures
Conduct internal random quality checks and assist with audit preparation
Ensure that all protocols are clearly understood by the assigned staff and that any areas of open interpretation are answered by sponsor/CRO prior to the initiation of a study
Verify potential subject meets inclusion/exclusion criteria per protocol
Monitor enrollment goals and enrollment timelines
Review all study monitors’ visit reports and respond promptly when required
Communicate information concerning subject's status to the investigator, sponsor and/or appropriate health care personnel
Maintain accurate records of medications/devices administered, delivered, and returned investigational substances and other sensitive confidential subject information
Assist Management in site performance, expansion, and growth enhancement strategies
Responsible for hiring, mentoring, and managing assigned personnel including performance evaluations, metric, and goal setting
Demonstrate professional communication and behavior which enable positive attitudes and trust by the subject population toward participation in clinical research
Support coordination and scheduling of pre-study site visits in a timely and appropriate manner
Assist with study initiation, identification, and recruitment of potential research subjects

Qualifications

Education/Experience:

RN/LVN or bachelor’s or master’s degree; or equivalent; or 5 or more years related experience and/or training; or equivalent combination of education and experience.

About Ark Clinical Research

At Ark Clinical Research, we strive to improve each patient’s quality of life through the development of more effective therapies and devices by conducting high quality clinical trials.

Job Type: Full-time

Pay: $35.00 - $40.00 per hour

Benefits:

401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Application Question(s):

We are currently looking for applicants in the OC or LA area. Please confirm you reside in the Southern California area.
What is your desired salary?
Do you have experience with any of the following areas in clinical trials MASH, CNS, Cardiovascular, Endocrine, GI?

Experience:

Clinical research: 5 years (Required)

Language:

Spanish (Required)

Work Location: In person

Ark Clinical Research

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