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Providence Health & Services Clinical Biorepository Program Specialist in Santa Monica, California

Description:

Providence is calling a Clinical Biorepository Program Specialist for a Full-Time/Day Shift to Saint John's Cancer Institute in Santa Monica, CA

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We are seeking a Clinical Biorepository Program Specialist who will function under the supervision of the Director of Clinical Research Operations, coordinating and maintaining diverse activities related to clinical research studies at the John Wayne Cancer Institute. Interacts closely with institutional investigators, biostatistics program and industry sponsors. Independently responsible for all aspects of non-treatment trials including but not limited to screening, prevention and biospecimen trials. Collaborates with the clinical staff, biostatistics abstractors and translational molecular medicine. Must uphold the standards of confidentiality, attendance and punctuality. Performs all duties in a manner which promotes team concept and reflects the Sisters of Providence mission and philosophy.

In this position you will:

  • Assist in development of clinical databases

  • Coordination of patients on non treatment cancer control, screening and prevention, 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 provides information pertinent to current clinical trials as they relate to patient cases presented

  • Assure collection and processing of biorepository specimens per discretion of investigators

  • Complete quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate

  • Establish and maintain procedures and systems (i.e., computerized database) for research coordination and data management. Develops and improves 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

  • Liaise between investigators and data abstractors to ensure accurate data collection

  • 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

  • Serve as a resource to provide support and guidance to less experienced CRA’s

  • Various competency based skills as supported by education and experience. (EKG, phlebotomy, vitals)

Qualifications:

Required qualifications for this position includes:

  • Bachelor's Degree

  • Current BLS – 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

  • Electronic data capture systems (InForm, Medidata Rave, etc.)

  • Designing case records forms, summarizing patient data and developing study reports; familiar with data verification and study audits methodology and principals

  • Experience with medical terminology

  • Thorough knowledge and understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance required

  • Advanced level proficiency in Microsoft Word, Excel, Internet, 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

Preferred qualifications for this position include:

  • Bachelor's Degree in Scientific or health services discipline

  • Master's Degree

  • ACRP/SOCRA certification or other Clinical Research Certification

  • Electronic data capture systems (InForm, Medidata Rave, etc.)

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 comprehensive, best-in-class benefits to our caregivers. For more information, visit

https://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 is a comprehensive not-for-profit network of hospitals, care centers, health plans, physicians, clinics, home health care and services continuing a more than 100-year tradition of serving the poor and vulnerable. 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: Administrative (Clinical)

Location: California-Santa Monica

Req ID: 309772

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