Providence Health & Services Clinical Research Associate II in Torrance, California
Providence is calling a Clinical Research Associate II (Full-time/Day Shift) to our John Wayne Cancer Institute in Santa Monica, CA.
Applicants that meet qualifications will receive a text or email with additional questions from our MODERN HIRE screening and interview system.
Please upload a current resume reflecting all relevant professional experience.
We are seeking a Clinical Research Associate II who will function under the supervision of the Clinical research Supervisor, coordinating and maintaining diverse activities related to clinical research studies at the John Wayne Cancer Institute. This includes, but is not limited to: patient screening, eligibility, registration, quality control of data compilation and submission, study evaluation, as well as direct patient follow-up by phone. Interacts closely with institutional investigators and industry sponsors. Independently responsible for all aspects of non-treatment trials including but not limited to screening, prevention and biospecimen trials. Collaborates with the Clinical Research Nurses throughout study completion for treatment and complex trials. Must uphold the standards of confidentiality, attendance and punctuality. Performs all duties in a manner which promotes team concept and reflects the Sisters of Providence mission and philosophy.
In this position you will have the following responsibilities:
Independently responsible for all aspects of clinical data management, including creation, and collection of source documents, completion of case reports forms, and tracking/reporting of serious adverse events. Captures/ enters data into clinical trial database as necessary.
Assist in the assessment and evaluation of potential research studies and patients for eligibility and feasibility. Collect and maintain complete records and statistics on each research study patient. Consolidate clinical data and reports for physician investigators as needed.
Coordination of patients on non treatment cancer control, screening and prevention, retrospective and repository trials (including screening, eligibility review, consenting, and ensuring completion of all protocol-required assessments).
Coordinate the collection of biospecimens for research projects and clinical trials conducted within Providence Health system. Arrange for review and submission of pathology materials and/or radiology materials as required per protocol.
Attend investigators meetings/various study related training and meetings.
Provide current and accurate protocol resources to investigators and staff. Attend cancer/tumor conferences and provides information pertinent to current clinical trials as they relate to patient cases presented.
Serve as a resource liaison for investigators and other researchers involved in the day to day management of patients on clinical trials. Provide support to individual physician investigators to ensure compliance with treatment plans and follow-up studies, and assesses outcomes. Conduct follow-up for assessment of off-treatment patients.
Liaise with sponsors when applicable and coordinate study drug shipments and accountability. Set-up monitoring visits and addresses monitoring reports.
Complete quality control audits to verify the accuracy, completeness, and confidentiality of research data. Report and address findings as appropriate.
Establish and maintain procedures and systems (i.e., computerized database) for research coordination and data management. Develops and improves research information systems.
Establish and promote positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research.
Assure ongoing informed consent process and patient advocacy during the process according to guidelines per Federal Office for Protection of Human Subjects.
Assure ongoing compliance with all system, regulatory, federal regulations and department policies. Maintain controls to assure accuracy, completeness and confidentiality of research data.
Prepare reports and assist with statistical preparation and analysis as necessary for audits or other presentations.
Maintain confidentiality standards for all potential and enrolled patients; comply with federal HIPAA regulations.
Serve as a resource to provide support and guidance to less experienced CRA’s.
Various competency based skills as supported by education and experience. (EKG, phlebotomy, vitals).
Required qualifications for this position includes:
Bachelor's Degree Scientific or health services discipline
CPR Current BLS-HCP – Basic Life Support - for Healthcare Providers - American Heart Association (AHA) or American Red Cross (ARC) - CPR/AED for Professional Rescuer accepted on hire until card expiration date
3 years Clinical Research professional managing Phase I-IV in house or pharmaceutical studies in compliance with GCPs and ICH Guidelines
Electronic data capture systems (InForm, Medidata Rave, etc.)
Designing case records forms, summarizing patient data and developing study reports; familiar with data verification and study audits methodology and principals
Experience with medical terminology
Thorough knowledge and understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
Advanced level proficiency in Microsoft Word, Excel, Internet, and e-mail
Works well with others and possess excellent communication skills and problem solving abilities
Highly organized and attentive to details
Communicates well with patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing; demonstrates high integrity and maintains confidentiality of all information
Interacts favorably with people by phone and in person, and work effectively as part of a team
Perform detailed, accurate computer entry functions. Good data entry skills
Highly motivated and able to take initiative
Able to manage multiple research projects within a fast paced environment; able to collect and manage large amount of data and maintain databases; communicates progress, challenges and results effectively
Involved in on-going quality review of documents generated for completeness and accuracy
Reports to work as scheduled and displays professional attitude
Preferred qualifications for this position include:
ACRP/SOCRA certification or other Clinical Research Certification
Significant experience with phase I-II and oncology studies
About the hospital you will serve:
The John Wayne Cancer Institute at Providence Saint John’s Health Center is a cancer research institute dedicated to the understanding and curing of cancer in order to eliminate patient suffering worldwide. The Institute's mission is accomplished by conducting innovative research focused on biological mechanisms to provide new understandings of the cause, diagnosis, control, and cure of cancer; training the next generation of surgical scientists who study and treat cancer; and researching unique experimental treatment services to rapidly develop and test new forms of diagnosis and therapy in order to improve the quality of life and expected survival of those afflicted with cancer.
We offer comprehensive, best-in-class benefits to our caregivers. For more information, visit
As expressions of God’s healing love, witnessed through the ministry of Jesus, we are steadfast in serving all, especially those who are poor and vulnerable.
Providence is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
Job Category: Research
Req ID: 325380