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Providence Health & Services Clinical Research Supervisor in Santa Monica, California

Description:

Providence is calling a Clinical Research Supervisor (Full Time, Day Shift) to John Wayne Cancer Institute in Santa Monica , CA.

We are seeking a Clinical Research Supervisor that will function under the supervision of the Senior Regional Research Manager, will supervise the day-to-day activities of Clinical Research Associates (CRA) and Research Assistants (RA) to ensure efficient and effective operations. The CRS will have the opportunity to participate in special projects and task forces as determined by management. Staff Management and Development-the CRS participates in the orientation, training and supervision of CRAs and RAs; participates in facilitating departmental trainings, align staff and resources with appropriate protocols and research needs; and maintains workflow consistency among staff and standardized processes. Operations Management-the CRS ensures that workflow is managed and monitored to meet departmental and service needs; assists with protocol activations, start-up activities, monitors research portfolio for workload by appropriately managing and identifying service needs. Quality Assurance-the CRS performs regular audits to ensure that the data collected is complete and accurate, and that the research project is carried out as planned. Regulatory Compliance-in collaboration with Regulatory department ensures that all appropriate Institutional, State and Federal regulations are followed throughout the course of a research project, database, or protocol. Also, the CRS will ensure that consenting process is conducted in compliance with rules and regulations and research protocols approved by the Institutional Review Board (IRB) and followed as written. Special Projects-participates or coordinates on both interdepartmental and intra-departmental organization-wide research projects as requested. The CRS will provide leadership, organization, creative, and other support to established and new research initiatives. The CRS would serve as back up to CRAs when needed. 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:

  • The Clinical Research Supervisor is responsible for supervision of a Clinical Research Associates and Research Assistances supporting the research service line. The Supervisor assists in the selection, training and orientation of personnel, recommends personnel actions and evaluates work performance

  • Participatesin hiring, onboarding, training, and supervision of CRAs and RAs

  • Provide leadership in developing and implementation of standardized processes among all site research teams

  • Supervise and monitor CRAs and RAs workflow to ensure research activities are conducted with strict adherence to the studies protocols and in compliance with existing rules and regulations

  • Allocate all necessary resources to ensure clinical, data collection and entry, and all other day-to-day activities coverage

  • Provide coverage at all stages of Clinical Trial performance

  • In collaboration with Regulatory department CRS ensures that all appropriate Institutional, State and Federal regulations are followed throughout the course of a research project, database, or protocol

  • Develop quality standards and programs; monitors and maintains quality of site performance

  • Provide current and accurate protocol resources to investigators and staff. Attend department conferences and provides information pertinent to current clinical research as they relate to patient cases presented

  • Ensure consenting process is conducted in compliance with all existing rules and regulations and site SOPs are being followed. Assists in timely research subjects updating with relevant protocols changes, re-consenting and making sure that clinical trials protocols are followed as written and approved by the Institutional Review Board

  • Participate in preparation to site monitoring visits, internal and external audits. CRFs monitoring to ensure data integrity through ALCOA

  • Act as liaison between sponsoring organization, investigators, physician, patient and all personnel involved in implementation of protocol to facilitate access to studies

  • CRS contributes in the research site growth and development and establishes and promotes positive working relationships within the department, throughout the hospital and between other institutions involved in clinical research

  • Participate in feasibility and SIV meetings facilitating site personnel training

  • Provide the physicians the protocols developments updates about opening and closing trials, and changes in enrollment. Collaborates with marketing department to expand clinical trial access to patients across the region

  • Generate accrual reports, data analysis and protocol development support

  • Coordinate implementation of protocol treatment, care, management and follow up of patients enrolled on highly complex research studies. Assists in patient eligibility verification, coordination of tests and procedures, patients’ education

Qualifications:

Required qualifications for this position include:

  • 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

  • 2 years experience with mentoring in research setting.

  • 3 years electronic data capture systems (InForm, Medidata Rave, etc.)

  • Experience with medical terminology

  • Ability to influence internal and/or external constituents

  • Ability to inspire and develop staff

  • Builds and manages effective teams

  • Excellent organizational skills

  • Highly thorough and dependable

  • Effective interpersonal skills

  • Demonstrated time management and priority setting skills

  • 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 possesses 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

  • 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:

  • 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

http://www.providenceiscalling.jobs/rewards-benefits/

Our Mission

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.

About Us

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.

Schedule: Full-time

Shift: Day

Job Category: Non-Clinical Lead/Supervisor/Manager

Location: California-Santa Monica

Req ID: 252484

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