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Providence Health & Services Clinical Research Coordinator II in Mission Hills, California

Description:

Providence is calling a Clinical Research Coordinator II (Full Time / Day Shift) to our Providence Facey Medical Foundation in Mission Hills, CA.

We are seeking for a Clinical Research Coordinator II who will be responsible for administratively supporting investigators during the conduct of multiple clinical research trials in accordance with the research center SOPs and all local, state, and federal regulations. Together with other team members, is responsible for coordinating enrollment, study visits and follow-up care of patients participating in clinical trials in various therapeutic areas. Act as the liaison between the sponsor (monitor), regulatory agencies, patients, investigators, nurses and all other staff during the trial. Participate in internal and external quality audits.

In this position you will:

  • Perform job functions timely and efficiently

  • Deliver upon the service expectations of both our patients and fellow staff members by listening to their needs; engaging in positive interactions; and following through on promises made in a thoughtful, efficient, timely and courteous manner so that their total outcome is better than expected

  • Respect the dignity, confidentiality and privacy of patients

  • Work in a safe manner, adhering to general safety precautions and standards. Report any unsafe conditions to their supervisor and/or the safety hotline

  • Act as primary CRC for multiple studies ranging in complexity of protocol or population

  • Consistently exceeds minimum CRC workload index

  • Support other primary CRCs in conducting screening visits for various studies

  • Conduct follow up visits for other studies as needed

  • Assist in training new research assistants and CRC I as needed

  • Participate in sponsor pre-study site visits

  • Support database queries and patient chart reviews in preparation for potential new studies

  • Establish lists of potential patients for upcoming studies

  • Evaluate new study set-up and logistics in preparation for implementation

  • Attend initiation meeting and/or investigator meeting

  • Receive, record and track all study test articles and supplies

  • Participate in study planning meetings with the research staff and other members of the research center as needed

  • Create source documents for clinical studies

  • Implement pre-determined recruitment plan

  • Contact patients for study screening visits and conduct screening visits

  • Provide study information to potential study subjects and obtain written informed consent

  • Schedule and conduct protocol visits

  • Maintain appropriate enrollment logs

  • Accurately complete Case Report Forms in a timely manner

  • Schedule and participate in monitoring visits from the sponsor

  • In conjunction with the investigators, identify all Adverse Events and complete proper paperwork and reporting

  • Work with sponsor to identify any data quality issues and resolve them effectively

  • Process and/or file appropriate IRB or sponsor related regulatory reports

  • Attend meetings with research team as scheduled/needed

  • Maintain study files with all appropriate paperwork

  • Perform final reconciliation duties at study closure (e.g., drug accountability and return, document filing)

  • Perform other duties as assigned by Research Manager

  • The customer service standards of the organization are reflected in daily work habits

  • Complaint are researched and responded to the same day if possible

  • Request from other departments are responded to in a timely, friendly and positive manner

  • When possible, take the initiative to offer help to co-workers in overload situations

  • Physicians and co-workers are treated courteously

  • Demonstrate behaviors, which are consistent with the Code of Conduct and aligned with the organization's mission, vision and shared values

  • Report promptly any suspected or potential violations to laws, regulations, procedures, policies and practices, and cooperates in investigations

  • Conduct all transactions in compliance with all company policies, procedures, standards and practices

  • Demonstrate knowledge of all applicable compliance and legal requirements of the job based on the scope of practice of the position

  • Ensure that appearance and personal conduct are professional at all times:

  • Excellent attendance record

  • Wear appropriate clothing for job functions

  • Work at maintaining a good rapport and a cooperative working relationship with staff and physician offices

  • Represent the organization in a positive and professional manner in the community

  • Maintain organizational and patient confidentiality at all time

Qualifications:

Required qualifications for this position include:

  • Bachelor's or Associate's Degree in medical field based education or Clinical technical training program

  • American Heart Association BLS for Healthcare Providers

  • 1 year experience as a Clinical Research Coordinator OR minimum 6 months experience as a Clinical Research Coordinator with advanced/specialized clinical or research technical skills

  • Thorough knowledge and understanding of Good Clinical Practices (GCPs); specifically 21 CFR 50, 21 CFR 54, 21 CFR 56, 21 CFR 312, and ICH/GCPs

  • Project management skills which include evaluation, organization, team and resource management

  • Excellent verbal and written communication skills

  • Excellent interpersonal, multi-tasking, and problem-solving skills

  • Ability to work with multiple protocols and shifting priorities

  • Ability to handle a study from initial planning to final paper work

  • Knowledge of Microsoft Office programs (Word, Excel, Outlook)

Preferred qualifications for this position include:

  • Spanish bilingual

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.

For information on our comprehensive range of benefits, visit:

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: Research

Location: California-Mission Hills

Req ID: 265271

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