Providence Health & Services Clinical Research Associate II in Santa Monica, California
Providence is calling a Full time, Day shift Clinical Research Associate II to John Wayne Cancer Institute in Santa Monica, CA.
We are seeking a Clinical Research Associate II that will function under the supervision of the Director of Clinical Research Operations, 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 provide 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. Conducts follow-up for assessment of off-treatment patients
Liaise with sponsor 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. Reports and addresses 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
Serve as a resource to provide support and guidance to less experienced CRA’s
Assure ongoing informed consent process and patient advocacy during the process according to guidelines per Federal Office for Protection o
Assure ongoing compliance with all system, regulatory, federal regulations and department policies. Maintains controls to assure accuracy, completeness and confidentiality of research data
Assure compliance with Medicare research funding rules and regulations by collaborating with pharmaceutical industry staff, private practice and health system billing staff. Assure appropriate billing and coding of patient services to correct research account
Prepare reports and assists with statistical preparation and analysis as necessary for audits or other presentations
Maintain confidentiality standards for all potential and enrolled patients; complies with federal HIPAA regulations.
Various competency based skills as supported by education and experience. (EKG, phlebotomy, vitals )
Required qualifications for this position include:
ACRP/SOCRA certification or other Clinical Research Certification
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
Preferred qualifications for this position include:
Bachelor's Degree in Scientific or health services discipline
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 a full comprehensive range of benefits - see our website for details
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 Health & Services is a not-for-profit Catholic network of hospitals, care centers, health plans, physicians, clinics, home health care and services guided by a Mission of caring the Sisters of Providence began over 160 years ago. 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
Location: California-Santa Monica
Req ID: 243015