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Clinical Research Coordinator Ii

Company

Sutter Health
Address , Palo Alto
Employment type FULL_TIME
Salary $40.85 - $61.28 an hour
Expires 2023-10-15
Posted at 8 months ago
Job Description

Organization:

PAMF-Palo Alto Research Institute

Position Overview:

Collects, compiles and presents clinical data for assigned area, ensuring accuracy, timeliness and accessibility of information. Maintains clinical and/or research databases for identified programs/ specialty clinics. Collects data used for multiple purposes, which may include process improvement activities and clinical effectiveness/research studies. May prepare information for patient/family education and/ or participate in community outreach activities.

:

JOB ACCOUNTABILITIES
CLINICAL TRIAL SUPPORT
  • Performs information management functions, including maintaining databases, entering and auditing data, may perform trending.
  • Creates and prepares specialized or complex reports, summaries, logs, or replies to inquiries, selecting relevant information from a variety of sources.
  • Maintains study subject records, regulatory binders, case report forms, source documents, investigational products and study supplies in according to policy and procedure.
  • Ensures the validity of research results by ensuring timely, accurate and complete data documentation both in electronic medical record and study case report forms, reporting deviations, violations and serious adverse events.
  • Mentors and fosters a constructive teaching environment that helps students and new teammates build confidence in their skills, knowledge and abilities.
  • Responsible for submitting protocol amendments, notices, suspensions, terminations, advertisements, and safety reports (adverse reaction reports) to SHCIRC and to physician investigators for review.
  • Drafts reports for protocols to be submitted for continuing review to the Sutter Health Central Area Investigational Review Committee (SHCIRC) and ensures they are submitted by the required due date.
  • Coordinates and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation.
  • Obtains samples, cultures, tissues and other specimens for analysis.

CLERICAL
  • Performs general clerical tasks, such as answering phones and greeting customers and patients on a daily basis.
  • Prepares and completes accurate, job related documentation, including collecting, updating, and maintaining patient data.

COMPLIANCE
  • Performs job responsibilities in compliance with department standards, policies, and procedures, as well as local, state and federal regulatory agencies to deliver the highest level of service.
  • Adheres to ethical practices during the conduct of clinical trials in order to protect the rights and well-being of patients and the collection of quality data.
  • Maintains strictest confidence of all patient protected health information (PHI) and protects all PHI from accidental, intentional, or inappropriate disclosure.
  • Ensures compliance with protocol guidelines and requirements of regulatory agencies.

EDUCATION
Equivalent experience will be accepted in lieu of the required degree or diploma.
Bachelor's: Science or health-related field or equivalent education/experience.

PREFERRED EXPERIENCE AS TYPICALLY ACQUIRED IN:
  • 2 years experience in retrospective data collection, patient interviewing, and interacting with a variety of patient populations in a variety of patient settings.
  • 2 years experience ensuring compliance with research regulations.
  • 2 years experience conducting clinical research.

Job Shift:

Days

Schedule:

Full Time

Shift Hours:

8

Days of the Week:

Monday - Friday

Weekend Requirements:

None

Benefits:

Yes

Unions:

No

Position Status:

Non-Exempt

Weekly Hours:

40

Employee Status:

Regular

Number of Openings:

1

This position may regularly work, store, prepare, receive, unpack, transport, dispose of, or administer drug(s) identified as hazardous, or potentially hazardous, by the National Institute for Occupational Safety and Health (NIOSH) for purposes of USP 800.

Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans.

Pay Range is $40.85 to $61.28 / hour

The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate’s experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package.