Sutter Health Clinical Research Coordinator II, GRAIL STRIVE Study - Sutter Institute for Medical Research (Elk Grove) (Full Time, Limited Term - Days) in Elk Grove, California

POSITION SUMMARY

The incumbent has responsibility for planning, initiating and studies that explore general medicine (acute and chronic) research questions. These studies are normally run longer than a year in duration and enroll 15 to 25 participants. With additional training and mentoring, the incumbent may be assigned studies that explore sub-specialty research questions. This is an exempt position that may require overnight travel and working weekends.

Limited Term, Grail Strive Project - 80 Weeks



About the STRIVE Study

The STRIVE Study is a prospective, multicenter, observational study of 120,000 women undergoing screening mammography. The purpose of the STRIVE Study is to train and validate a test for detection of breast cancer. The cohort will also be utilized to train and develop a pan-cancer test.

PRINCIPLE ACCOUNTABILITIES

I. *CONDUCTS RESEARCH TRIALS* **

Study Management

· Attends meetings with sponsors as required to ensure that study protocols, FDA requirements and Sutter Hospital Institutional Review Committee requirements are followed.**

· Manages assigned trials in accordance with Protocol and amendments, sponsor guidelines, and departmental operating procedures and instructions.**

· Reports status of all research participants and assigned projects as may be requested.**

· Prepares study management plan, as requested.**

· Promotes sponsor visits to site for assessing capabilities.

· Actively seeks out new or follow-on studies.**

Planning

· Participates in protocol review with feasibility team.

· Assists with estimating resource needs for study conduct.

· Collects data for determining source(s) of qualified patients.

· Interfaces with appropriate Departments and area physicians to identify patient population.

· Attends investigator meetings.

· Prepares or assists in preparation of consent forms and other regulatory documents.

· Attends IRB meetings, as required.

· Responds accurately and quickly to IRB requests for additional information and periodic reports.

· Coordinates and conducts study team meetings.

· Interfaces with appropriate Departments for support (as required) from radiology, laboratory, site operations, etc.

Initiation

· Prepares source documents.

· Prepares advertisements and screening questionnaires.

· Performs database search for potential patients.

· Reviews medical charts for qualified patients.

· Responds quickly and knowledgeably to requests for information about currently enrolling clinical trials and current treatment options.

· Schedules, attends, and coordinates study initiation visits.

Patient Accrual

· Strives to achieve patient recruitment goals.**

· Attends community-based activities to promote participation in clinical research studies.**

· Performs accurate and complete screening of potential research subjects.

· Provides accurate and complete information regarding study participation to patients and family members including presenting, witnessing and providing a copy of informed consent.

Maintenance

· Collects and records accurate patient study data.**

· Collects and maintains all patient data source-documents, including chart notes, laboratory reports, physician dictation, etc.

· Completes Case Report Forms (CRF) and other study documents immediately following patient visits and/or receipt of source documents.

· Schedules and completes patient visits and study documentation according to Good Clinical Practices.**

· Dispenses study medications in accordance with Protocol and physician instructions.**

· Obtains laboratory specimens and performs laboratory procedures as indicated.**

· Prepares and ships laboratory specimens in accordance with Study guidelines.**

· Provides telephone support to patients involved in clinical research projects.

· Keeps accurate and complete documentation of all patients referred for enrollment into clinical trials such as: complete demographic information, concomitant medications, concurrent illnesses, medical history, and treatments.

· Maintains complete and accurate performance statistics to include: (number of) patients screened, patients screen-failed, patients randomized to drug, dropped out, and completed.

· Provide initial and periodic correspondence between principal investigator and participant’s primary physician i.e. laboratory values, study outline and patient status.

· Interact in a positive manner with pharmaceutical sponsors and Clinical Research Associates as required for completion, review or auditing of research documents.

Regulatory Compliance

· Maintains contact with study participants and physicians and documents AE/SAE’s or interventions as reported by participants or as directed by principal investigator.

· Follow Standard Operating Procedures as defined for Research Coordinators so that Quality Assurance in all aspects of research is attained.

· Maintains or oversees maintenance of all study binders, including regulatory and case report forms, in accordance with applicable FDA regulations, Good Clinical Practices, and State ofCaliforniaregulatory guidelines.

Closeout

· Participates fully with sponsor representatives during all monitoring visits.

· Responds quickly and accurately to requests for information.

· Completes all corrections/clarifications to data records quickly and accurately.

· Prepares study binders and other documents for archiving.

· Summarizes final performance reports.


II. PROVIDES SUPPORT TO COWORKERS ON AN “AS NEEDED” BASIS **

· Provides assistance to coworkers regarding screening, enrollment, maintenance and completion of participant study visits and data collection.

· Provides telephone and written contact to area referring physicians regarding the purpose of a variety of research studies.

· Maintain current knowledge of medical research, treatment and research documentation through continuing education and participation in pertinent professional groups.

III. ORGANIZES GENERAL ASPECTS OF ASSIGNED STUDIES

· Works well independently and prioritizes work assignments.

· Determines the most accurate methods of data collection.

· Completes work within established time frames.

· Keeps accurate records of research related expenditures.

· Keeps an accurate record on all study patient visits.

· Coordinates meetings by and between SIMR administration, Pharmaceutical Sponsor(s), physicians and healthcare professionals, as may be required.

IV. PROMOTES PARTICIPATION IN CLINICAL TRIALS **

· Conveys the theoretical and technical aspects involved in each study to potential participants, referring physicians and allied health professionals.

· Exchanges data and correspondence with other researchers as indicated.

· Establishes a close working relationship with personnel from appropriate departments within Sutter Health and other health providers to obtain accurate and complete study information.

· Keeps research physicians informed of issues and concerns related to assigned research trials.

· Exercises effective problem solving abilities with a variety of people including hospital personnel, patients and public.

· Acts as consultant to support service nursing staff, physicians and other health care professionals.

· Integrates current research opportunities into local clinical settings.**

· Actively seeks information regarding new clinical trial opportunities.**


V. UNIVERSAL CRITERIA **

Commitment to Quality

· Demonstrates commitment to total quality management through knowledge of its precepts, skillful workplace applications and continuous organizational improvement.

· Exhibits a customer/supplier philosophy that emphasizes both internal and external relationships; identifies both customer and supplier needs/expectations and strives to exceed them.

· Actively participates in, and encourages others to utilize creative and innovative approaches to accomplish tasks, i.e., “Ideas at Work,” “Sutter Share Quality Indicators.”

· Demonstrates responsibility for ongoing personal development, professional growth and continuing education.

Planning and Time Utilization

· Performs duties in a self-directed manner with minimal supervision or direction.

· Ensures that routine and priority tasks are completed within established departmental time frames.

Policies and Procedures

· Consistently adheres to department and facility policies and procedures.

· Attends and actively participates in department and facility meetings and classes, including annual fire, safety, and disaster programs.

· Follows safety procedures, operates equipment and performs job related duties in a safe manner which prevents accidents from occurring.

· Observes the departmental dress and grooming code standards and consistently wears facility identification badge.

Attendance and Reliability

· Sick or absent time off does not exceed the facility guidelines as outlined in the Personnel Policy manual.

· Provides proper notification of absence or tardiness within established department time frames.

MINIMUM POSITION REQUIREMENTS:

· Education:

  • BS degree in Biology or Health Sciences or a BA degree with 5 years experience health field required.

  • Course work in medical terminology and procedures is preferred.

  • Must be able to speak, read, write and understand the English language.

·Achievement of certification as CCRP, CCRC, or CCPRA - clinical research coordinator certification required. SoCRA or ACRP Certification valid.

· Experience:

· Minimum of two years experience conducting clinical research is required.

· Experience in retrospective data collection, patient interviewing, and interacting with a variety of patient populations in a variety of patient settings is required.

· Experience demonstrating the ability to work with minimal supervision and the ability to prioritize and organize work is required.

· Knowledge:

·Thorough knowledge and understanding of FDA regulations protecting human subjects in research is required. Basic understanding of safeguarding confidential information required.

·Must have basic clinical skills to obtain patient vitals (measure pulse, respiration rate, blood pressure, EKG, height and weight, draw and process blood samples).

First-hand knowledge of hospital policies and patient care standards is desired

Organization: *Sutter Valley Hospital

Title: Clinical Research Coordinator II, GRAIL STRIVE Study - Sutter Institute for Medical Research (Elk Grove) (Full Time, Limited Term - Days)

Location: California-Greater Sacramento Area-Elk Grove

Requisition ID: SVH-1719991

All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, marital status, sexual orientation, registered domestic partner status, sex, gender, gender identity or expression, ancestry, national origin (including possession of a driver's license issued to individuals who did not present proof of authorized presence in the U.S.), age, medical condition, physical or mental disability, military or protected veteran status, political affiliation, pregnancy or perceived pregnancy, childbirth, breastfeeding or related medical condition, genetic information or any other characteristic made unlawful by local, state, or federal law, ordinance or regulation. External hires must pass a background check/drug screening. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state, and local laws, including but not limited to the San Francisco Fair Chance Ordinance.