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

Qm95UW8yMUxBekNQUVBBakNSM2F6MDcyOHc9PQ==
  • SF Research Institute
  • San Mateo, 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

Made In Nature

Plant Cost Accountant Job at Made In Nature

 ...production. Work closely with Customer Service to forecast demand and adjust production schedules as needed to meet customer orders and seasonal fluctuations. Identify areas of improvement in the production planning and scheduling process, and work with senior leadership... 

Russell Tobin

Mask Layout Designer III Job at Russell Tobin

The Scientific Team at Russell Tobin & Associates is hiring a Mask Layout Designer III for a world-class client in Cupertino, CA, 95014 Required top skills: -This role is for an experienced Mask Layout Designer who specializes in analog circuit design layout for System...

Oldcastle Infrastructure

Welder/Fabricator Job at Oldcastle Infrastructure

 ...safety-first mindset. Job Summary Assemble or fabricate mechanical parts, pieces or products using a variety of tools and...  ...blueprints, diagrams, engineering drawings, specifications, weld symbols, bills of materials, and other written instructions or... 

Legacy Health

RN Staff Nurse - Medical Surgical ICU Job at Legacy Health

 ...Surgical Intensive Care Unit located 12 miles SW of Portland. Our ICU provides care to patients who are seriously ill or at high risk...  ...relevant Standards and Scope of Practice for the Registered Nurse. The RN Staff Nurse assesses, analyzes, plans, implements and evaluates... 

Codex

Senior Financial Analyst Job at Codex

 ...Senior Financial Analyst - Remote (NYC) - $80-110K A leading national nonprofit organization is seeking a Senior Financial Analyst...  ...Analysis (FP&A) team. This is an outstanding opportunity for a finance professional who is passionate about using their expertise to...