Research Project Director

Chapman University Careers•Irvine, CA

1d•Hybrid

About The Position

Provide part-time project direction for a clinical research study at AltaMed (in collaboration with Chapman University). In collaboration with the Principal Investigator, provide clinical leadership and exercise independent clinical judgment and sound decision-making in conduct of clinical research. This includes participant assessment and evaluation of eligibility for the study; overseeing recruitment of those participants; clinical management and protocol-related determinations; monitoring study progress and milestone achievement; communications with key stakeholders; oversight of protocol compliance; and managing activities related to research dissemination.

Requirements

Doctoral degree in a clinical healthcare profession from an accredited medical institution
Demonstrated experience providing direct patient care and exercising clinical judgment and medical decision-making in the evaluation, diagnosis, treatment, and management of patients.
Experience collaborating with healthcare providers, conducting clinical assessments, and serving on multidisciplinary research teams.
Knowledge of clinical research methodologies, human subjects protections, IRB requirements, and regulatory standards governing clinical research.
Strong scientific and medical writing skills, with the ability to contribute to and author abstracts, manuscripts, presentations, posters, and peer-reviewed publications.
Excellent verbal and written communication skills with the ability to communicate complex clinical and scientific information to patients, healthcare providers, investigators, sponsors, and other key stakeholders.
Excellent organizational, and project management, and leadership skills with the ability to manage multiple study activities, clinical responsibilities, timelines, and competing priorities while maintaining scientific rigor and participant safety.
Demonstrated experience with clinical research protocols, participant recruitment and enrollment, study conduct, and clinical oversight of research activities.

Nice To Haves

Eligibility for or possession of a current and unrestricted medical license preferred.

Responsibilities

Direct overall study operations and clinical implementation across the Los Angeles and Anaheim clinic sites, ensuring adherence to study protocols, applicable regulations, and standards of medical practice.
Manage study communications, including with external physicians for PrEP patient referrals to the clinical research study.
Maintain patient contact lists and correspondence tracking in line with all applicable confidentiality laws.
Provide physician-level clinical oversight for participant recruitment, which includes pre-screening, evaluation for eligibility, enrollment, and retention activities.
Assess potential participants’ medical histories, clinical presentations, laboratory findings, and risk factors to determine study eligibility, appropriateness for enrollment, and ongoing participation in accordance with protocol requirements and accepted standards of medical care.
Maintain oversight of study progress, recruitment and enrollment milestones, protocol compliance, participant safety, participant visit compliance, and study deliverables.
Identify and resolve clinical and operational risks as necessary.
Review, assess, and direct responses to protocol deviations, clinical exceptions, and participant-specific issues requiring medical judgment.
Retain documentation of such issues in line with all applicable confidentiality laws.
Utilize professional medical expertise to interpret protocol requirement and apply clinical judgment in situations not specifically addressed by study procedures while ensuring compliance with IRB and regulatory requirements.
Draft and contribute substantive clinical content for abstracts, manuscripts, presentations, and regulatory reports.
Serve as co-author on scientific publications and presentations arising from the study.