Providence is calling a Clinical Research Associate I (Full Time/Day Shift) to Providence John Wayne Cancer Institute, Santa Monica, CA.
We are seeking a Clinical Research Associate I who will function under the supervision of the Director, Clinical Research Operations, coordinating and maintaining diverse activities related to clinical trials 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. Interact closely with institutional investigators and industry sponsors. Collaborate with the Clinical Research Nurses throughout study completion. Must uphold the standards of confidentiality, attendance and punctuality. Perform 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:
Serve as department preliminary screener for potential trials
Support & assist in 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. Capture/ enter data into clinical trial database as necessary. 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 in follow up on treatment trials, patients on non treatment cancer control, and 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. Arranges 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
Serves as a resource liaison for investigators and other researchers involved in the day-to-day management of patients on clinical trials. Provides support to individual physician investigators to ensure separate compliance with treatment plans and follow-up studies, and assesses outcomes. Conducts 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
Assist with quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate
Assist in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management. Assist to improve 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. 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:
Bachelor's degree or equivalent experience
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
Two years research or clinical research data entry experience required; Specifically in medical terminology, tumor registry, or clinical research.
Thorough knowledge and understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
Proficiency in Microsoft Word, Internet, Excel, and e-mail
Work well with others and possess excellent communication skills and problem solving abilities
Highly organized and attentive to details
Communicate 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
Interact 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 required
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
Report to work as scheduled and displays professional attitude
Preferred qualifications for this position include:
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.
Providence Health & Services