Clinical Research Coordinator Job at SF Research Institute, San Francisco, CA

TzBFRXZmVkE0T29zMUQ5RVU3WDR2ejFkTlE9PQ==
  • SF Research Institute
  • San Francisco, CA

Job Description

Clinical Research Coordinator

Overview

As a Clinical Research Coordinator, you will lead the study team and be responsible for the execution of complex clinical trials from study design through study close out. You will be responsible for business and financial management of our research site, as well as oversight of day-to-day operations.

Responsibilities

  • Perform daily oversight and business management of all trials from start to study closure
  • Coordinating, monitoring, and supervising all aspects of clinical studies from start-up to closeout, to ensure proper execution of assigned clinical research trials and to ensure that study protocols are me
  • Preparing and maintaining administrative logs and trackers, including Regulatory Documents Collection tracker, eTMF tracker, Health Canada submission tracker, Central IRB Submission tracker, Site Shipments tracker, study visits, etc.
  • Package, label, process, and ship specimen, filing and tracking of study visits, survey documents, including monitoring reports and study source documents
  • Serve as primary contact for sponsors regarding new studies, submission, IRB, IMVs, PSV and renewals
  • Perform oversight of clinical activities, NDA, FQ, site qualifications, and site initiation management
  • Manage trial feasibility process and oversee site capability assessments in collaboration with the sponsor team
  • Ensure trials follow in accordance with ICH/GCP standards and SFRI’s SOPs
  • Participate in review of clinical data to ensure readiness for QA and IRB regulatory audits
  • Assist regulatory staff with maintaining accurate information in all regulatory documents and study binders
  • Review clinical monitoring reports to ensure identification of site issues and implement corrective actions
  • Oversee and lead patient recruitment, advertising, screening, and enrollment, and data entries
  • Lead research staff to meet deadlines, and support quality and profitability
  • Track budgets and report expenses to contribute to budget forecasting
  • Oversee the drafting of site materials including training, manuals, and support documentation
  • Evaluate and provide revisions on protocols and clinical and regulatory documents
  • Lead weekly staff meetings related to BF, staffing, expenses. A/R, payable, study protocols clinic updates, and research activities
  • Conducts interviews, hiring, and reviews for study team
  • Ensure proper use and maintenance of all study equipment, inspections and calibrations.

Education

  • B.A./B.S. degree (or equivalent combination of education and experience) in Health Sciences or related field

Required Skills

  • 2+ years experience in coordinating clinical trials
  • Licensed Phlebotomist/Vaccination administration
  • Relevant experience across more than one phase of development, and across the entire lifecycle of a study
  • Excellent organization and attention to detail
  • Quick and eager learner
  • Ability to work independently
  • Strong critical thinking
  • Professional demeanor
  • Excellent oral and written communication

Preferred Skills

  • 2+ years of experience in related fields (MA, CNA, LPN)
  • Experience in the Biopharmaceutical industry, Dermatology, Esthetics, Dietary Supplements or Ophthalmology, or Internal Med, Infection, Ob Gyn, Neurology, Cardiology or GI studies
  • Experience working with young patient groups and diverse communities

Job Tags

Similar Jobs

TPI Global Solutions

Graphic Designer Job at TPI Global Solutions

 ...Jackson, MI 49201 Work Schedule: Hybrid (On-site: Monday, Tuesday, Thursday | Remote: Wednesday, Friday) Position Summary: CMS Energy is seeking a Graphic Designer I to join our dynamic communications team. This role is responsible for creating original, engaging... 

Great Clips

Hourly rate Hair Stylist - Coal Mine Shopping Center Job at Great Clips

 ...Well Provide*: A steady flow of customers - no current clientele required Guaranteed hourly wages and tips Flexible scheduling that fits your needs (full-time and part-time shifts may be available) Opportunities to sharpen your shearserr we mean skills, with... 

LHH

Commercial Real Estate Associate Job at LHH

 ...Commercial Real Estate Attorney/Associate Top Richmond law firm seeking experienced Commercial Real Estate Attorney/Associate . The successful candidate will focus on various aspects of commercial real estate transactions , including acquisitions, leasing,... 

Arizona Complete Health

LTSS Service Care Manager Job at Arizona Complete Health

 ...* Assists in developing, assessing, and coordinating holistic care management activities to enable quality, cost-effective healthcare outcomes. May develop or assist with developing personalized service care plans/service plans for long-term care members and educates members... 

KODIAK Construction Recruiting & Staffing

BIM Designer Job at KODIAK Construction Recruiting & Staffing

Our Benefits ~ Exceptional health, dental and vision insurance. ~ Paid Employee Only Medical Coverage ~ In house and manufacturer led training, leadership development ~ Long-term career growth into operations, sales and/or leadership ~ Comprehensive benefit package...