Providence Health & Services Clinical Trials Supervisor Oncology in Torrance, California
Providence is calling a Clinical Trials Supervisor Oncology (Full Time/Variable Shift) to John Wayne Cancer Institute in Torrance , CA.
We are seeking a Clinical Trials Supervisor Oncology that will function under the supervision of the Director, Clinical Research Operations, to assist in leading the Research service line in implementing and developing clinical trial process and procedures to expand clinical trial access to patients across the region. The Clinical Trials Supervisor will be responsible for supervision of a Clinical Research Coordinator or Data Coordinator supporting the research service line and coordinating and maintaining diverse activities related to clinical trials across the California region. Independently responsible for all aspects of treatment related clinical trials falling under the purview of the Oncology service line in the acute care and outpatient setting. This includes supporting Providence clinical trial activities in the private practice physician office across the region. Coordinates implementation of protocol treatment, care, management and follow up of patients enrolled on highly complex research studies. The Clinical Trials Supervisor will be primarily responsible for patient eligibility verification, coordination of tests and procedures, education of patients, families, Nursing and Medical staff, coordination of investigational vaccines and oral agents, patient advocacy, and assurance of compliance with Federal and International Human Subjects Regulations. Performs all duties in a manner which promotes a team concept and reflects the Sisters of Providence mission and philosophy.
In this position you will have the following responsibilities:
Be responsible for supervision of a Clinical Research Coordinator of Data Coordinator supporting the Oncology-research service line. The Supervisor assists in the selection, training and orientation of unit personnel, recommends personnel actions and evaluates work performance
Assist in the development and implementation of regional and system wide clinical trial processes and procedures to expand clinical trial access to patients across the region
Assist in the development and implementation of regional and system wide policies to guide research activities that advocate for patients, support FDA and other federal human subjects regulations, to assure protocol compliance
Be responsible for coordinating and maintaining diverse activities related to clinical trial nursing across the Southern California region
Independently responsible for the adherence of treatment related to clinical trials falling under the purview of the Oncology service line in the acute care and outpatient setting, including supporting Providence clinical trial activities in the private practice physician offices across the region. This includes but is not limited to registry, device, medical, surgical, and outcomes research
Support Providence clinical trial activities in private practice physician offices where main responsibility will be subject recruitment for treatment studies from many diverse research agencies at levels to meet accrual commitments
Coordinate implementation of protocol treatment, care, management and follow up of patients enrolled on highly complex research studies. This includes patient eligibility verification, coordination of tests and procedures, education of patients, families, Nursing and Medical staff, coordination of investigational vaccines and oral agents, patient advocacy, and assurance of compliance with Federal and International Human Subjects Regulations
Evaluate operative reports, pathology reports, diagnostic test reports, inpatient and outpatient medical records to determine eligibility, or significance of toxicities to investigational therapy
Coordinate diagnostic, surgical and other procedures, exams, and specimen collection. Coordinates specimen collections and adherence to applicable federal regulations
Work with the physician to provide ongoing research related assessments of patients enrolled to complex early phase treatment clinical trials, develops research plan of care according to patient needs. Documents all clinical observations to assure and maintain high quality research necessary for meaningful clinical trials, while assuring appropriate patient interventions and education conducted to address identified patient problems
Provide guidance and support to the research department staff. Act as a clinical resource for patient issues relevant to research
Provide clinical research education and in-services to internal and external stakeholders such as inpatient units, cardiac cath lab, special procedures, floor nurses, private practice physician office staff and other medical or nursing staff regarding investigational therapy, potential toxicities, protocol procedures and available resources
Provide current and accurate protocol resources to investigators and staff. Attend department conferences and provides information pertinent to current clinical trials as they relate to patient cases presented
Maintain confidentiality standards for all potential and enrolled patients; complies with federal HIPAA regulations.
Participate in the protocol review and feasibility processes and work with the hospital and physician practice to analyze clinical research protocols to assure clarity of standard vs. non-standard care requirements (important for billing implications).Collaborate with physicians and other care givers to identify appropriate studies to meet the needs of our patients
Assure ongoing informed consent process and patient advocacy during the process according to federal regulations and guidelines per the Office for Human Research Protections
Assure ongoing compliance with all Federal regulations and department policies for regulatory documentation of research processes. Appropriately assures compliance with regulations regarding handling and administration of gene therapy materials or other strictly controlled investigational agents
Assure compliance with all system and regulatory Quality Assurance requirements. Institutes controls to assure accuracy, completeness and confidentiality of research data. Prepares reports and assists with statistical preparation and analysis as necessary for audits or other presentations
Act as quality assurance gatekeeper for assurance of enrollment, evaluation and treatment of patients according to protocol, preventing research bias and protecting integrity of all data. Attention to protocol requirements prevents intentional or unintentional research fraud
Act as liaison between sponsoring organization, investigators, physician, patient and all personnel involved in implementation of protocol to facilitate access to studies
Establish and maintain procedures/systems for research coordination and data management. Collects and maintains complete records and statistics on each research study patient
Promote the image of Providence Health & Services through involvement in community events, outside organizations and educational programs
Attend regional and health system meetings. Participate in system wide research workgroups
Attend investigator meetings/various study related training and meetings
Establish and promote positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research
Generate accrual reports, data analysis and protocol development support
Required qualifications for this position include:
Associate's Degree in Nursing
Current CA Licensed Registered Nurse
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 Clinical research with a Master’s Degree in Nursing
4 years Clinical research with a Bachelor’s Degree in Nursing
6 years Clinical research with an Associate’s Degree in Nursing
Knowledge and ability to supervise Clinical Research Coordinators or Data Coordinators supporting the Oncology-research service line, including assisting in the selection, training and orientation of unit personnel, recommending personnel actions and evaluating work performance
Maintain current nursing knowledge related to assessment, planning, implementation and evaluation of care of fragile and/or chronically ill adult and geriatric patients
Knowledge of current practices in nursing, including outcome standards, nursing management of disease and treatment, complications and psychological response
Strong understanding of Oncology, pathophysiology, etiology, risk factors, characteristics, diagnosis, and treatment with knowledge of both current standard and novel investigational therapies. Competence in intercultural nursing care and communication
Ability to assess and triage patient issues quickly and accurately.
Ability to prioritize implementation of Oncology patient care in the chronically ill and/or fragile patient population
Ability to coordinate patient care among primary care, care providers.
Strong patient, family and staff/care provider teaching skills
Knowledge of current practices in cancer nursing including outcome standards, nursing management of disease and treatment complications and psychological response
Strong written and verbal communication skills
Strong attention to detail
Ability to anticipate patient problems or care coordination issues related to high complexity of protocol requirements that deviate from standard care
Ability to act as patient advocate
Ability to work cooperatively with variety of individuals including physicians, nursing, administrators, private practice staff, industry and federal research sponsors, study auditors, billing staff, pharmaceutical industry representatives and community leaders
Ability to function as coordinator for community events representing the research department
Preferred qualifications for this position include:
Bachelor's Degree in Nursing
Certification in area of nursing specialization (i.e. OCN, RN-BC, NIH Stroke)
ACRP/SOCRA certification or other Clinical Research Certification
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: Non-Clinical Lead/Supervisor/Manager
Req ID: 249639