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Clinical Research Coordinator (SOMA / south beach) - Biotech, R&D, & science - San francisco bay area

Ad ID: 739322
Posted by: Unregistered user
Posted on Nov 14, 2017
Expire: Feb 12, 2018

Company: University of California, San Francisco
Position Title: Clinical Research Coordinator
Department: Pediatrics Endocrinology
Location: Mission Hall - Mission Bay
Position Type: Full Time
Percentage: 100%
Work Days/Shift: 8:30 am - 5:00 pm (occasional evenings & weekends)
Requisition #: 48260BR
JOB OVERVIEW
The Clinical Research Coordinator (CRC) will join the Division of Pediatric Endocrinology and responsibilities will include coordination of clinical research studies related to type 1 diabetes
The CRC will perform independently at the fully operational level to execute, manage, and coordinate research protocols as directed by the Principal Investigator (PI) and/or Clinical Research Manager; may coordinate the data collection and operations of several concurrent interventional clinical research studies under the guidelines of research protocols, UCSF and regulating agency policies

The CRC position will focus on observational and intervention clinical trials related to type 1 diabetes mellitus
The overall goal is to help the diabetes research team successfully conduct clinical trials for people with established or recent-onset type 1 diabetes, and help prevent type 1 diabetes for at-risk families
The person in this job will be instrumental in success of recruitment & retention of research subjects, screening and enrollment into the studies, and conduct of the studies over time
Specifically, the CRC will inhabit the role of lead study coordinator for observational, prevention, and interventional clinical trials within major NIH consortiums such as Type 1 Diabetes TrialNet and the Immune Tolerance Network
This CRC will occasionally present T1D information and current enrollment opportunities to families, caregivers, and other stakeholders at informational and screening events.
The CRC's duties may include, but not be limited to, management and coordinating the tasks of multiple clinical trials varying in their size and complexity, act as intermediary between services and departments while overseeing data and specimen management; manage and report on study results; create, clean, update, and manage databases and comprehensive datasets and reports; coordinate staff work schedules, assist with training of or oversight support of other research staff, interns, or affiliate coordinators; manage Investigator's protocols in the IRB online system, including annual renewals and modifications of protocol applications and the implementation of new studies; help assure compliance with all relevant regulatory agencies; oversee study data integrity; implement and maintain periodic quality control procedures; interface with departments to obtain UCSF approval prior to study initiation; maintain all regulatory documents; report study progress to investigators; and participate in any internal and external audits or reviews of study protocols

The CRC will help insure that all aspects of the studies comply with NIH standards of good clinical research practices
This includes protection of the experimental subject's right as well as maintaining proper source documentation for each subject
The individual will have the opportunity to be involved in all aspects of the clinical research projects; however, this person will primarily help with the screening and enrollment, management of subjects within study protocols, and preparation of documents for the Institutional Review Board and other regulatory agencies; specimen collection, sample shipping and tracking
Accurate and timely communications with subjects, PIs, sponsors, and our Institutional Review Board will be an essential part of the job

PEDIATRIC ENDOCRINOLOGY
The Division of Pediatric Endocrinology provides expert care for young patients with common and rare endocrinological conditions at UCSF Benioff Children's Hospital
Our division offers a range of training oppaortunities, from clinical rotations for medical students to advanced fellowship training
UCSF is widely recognized for its research in pediatric endocrinological disorders.
ABOUT UCSF
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care
It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences

REQUIRED QUALIFICATIONS
• High School graduation (or GED equivalent) and six months to one year of relevant work experience, or a combination of education and work experience; and demonstrated skills to successfully perform the assigned duties and responsibilities
• Excellent and effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions
Excellent interpersonal skills
• Ability to multi-task in a fast-paced environment while working with a diverse subject population
• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines
Self-motivated, and okay with occasional ambiguity
• Excellent organization skills; exceptional attention to detail
Note: Physical/health screening, fingerprinting and background check required.
PREFERRED QUALIFICATIONS
• Bachelor's degree in science or health-related field, or an equivalent combination of education and experience
• Current and active certification in both Good Clinical Practice (GCP) Guidelines and Human Research Subjects Protection; and proven real time experience applying the regulations and guidelines
• Certified phlebotomist, experience with children & adults
• Three to five years of work experience as lead CRC, or in a medical, academic, or CRO setting
• Comprehensive coordination of multiple studies of high complexity (industry, government, or investigator driven research) with significant study enrollment per study
Can be in/of varied disciplines
• Experience performing writing consent/assent forms for various research protocols; including performing consent/assent to children and adult participants
• Prior experience with tracking adverse events in clinical trials and adherence to reporting mandates to appropriate regulatory bodies per protocol and IRB guidelines
• Prior experience with specimen collection and processing, and regular packing/shipping infectious substances, working in close collaboration with clinical and investigational laboratories
• Advanced knowledge of monitoring and data collection procedures; advanced and current knowledge of FDA regulations related to the conduct of research
• Advanced knowledge of proper source documentation practices and eCRF
• Working knowledge of type 1 diabetes, and experience coordinating type 1 diabetes clinical research studies
• Working knowledge of UCSF electronic medical records (Apex)
• Knowledge of medical terminology, research policies and guidelines, database building/analysis, and data management platforms
• Thorough knowledge & usage of UCSF Institutional Review Board (IRB) processes, including proven track record using the online iRIS system for submission, renewal, and modification of protocols through this system
• Understanding of type 1 diabetes patient population to create rapport and a relationship, while also giving insight to what is realistic and appropriate for patient participation
• Knowledge of UCSF and departmental policies for dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.)
• Knowledge of medical terminology, research policies and guidelines, guidelines for packing/shipping infectious substances, and data management; knowledge of the UCSF budget, grants and industry contracting processes
• Experience applying the following regulations and guidelines:
Health Information and Accountability Act (HIPAA)
IRB/CHR regulations for recruitment and consent of research subjects
Effective Petty Cash Handling Procedures
Environmental Health and Safety Training
In order to be considered for open positions at UCSF, you will need to submit your resume through our online application process
Once you complete the online application process, you will receive an email confirming that your submission has been received
Submitting your resume to UCSF opens the door to many immediate and ongoing job opportunities
Your resume will remain active in our applicant database and you will be able to update it as needed

To submit your resume Click Here
Emailed applications are not accepted.
Apply specifically to requisition # 48260BR Please note ad code ICRL/ # 48260BR in the ad code field in your applicant profile.
An email address is required for you to submit your resume

The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
  • Principals only
    Recruiters, please don't contact this job poster.
  • do NOT contact us with unsolicited services or offers

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Expire: Feb 12, 2018
Posted on Nov 14, 2017

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