Providence Health & Services Clinical Research Associate I in Mission Hills, California
Providence is calling a Clinical Research Associate I (Full Time/Day Shift) to our Providence Facey Medical Foundation in Mission Hills, 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:
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. 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 separate 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
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. Maintain 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 assist 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)
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
2 years Research or clinical research data entry experience; Specifically in medical terminology, tumor registry, or clinical research
Thorough knowledge and understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance required
Proficiency in Microsoft Word, Internet, Excel, and e-mail are required
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 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
Reports to work as scheduled and displays professional attitude
ACRP/SOCRA certification or other Clinical Research Certification
Experience with Electronic Data Capture systems (InForm, Medidata Rave, etc.)
About the organization you will serve:
Facey Medical Group is a multi-specialty medical group with over 160 physicians providing care to the growing population in the North & East regions of Los Angeles & Ventura Counties. Twelve medical clinics, including two urgent care centers and dedicated women's centers, are located across the San Fernando, Santa Clarita and Simi Valleys. The group began as a single medical practice over 90 years ago.Facey is part of Providence Health & Services, an integrated, not-for-profit 5-state network of hospitals, care centers, medical clinics, affiliated services and educational facilities spanning from California to Alaska.
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-Mission Hills
Req ID: 259832