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Clinical Research Coordinator Assistant

Wilmington
Permanent
Reference: JR071528
This vacancy has now expired.
Description

Recruiting now for a Clinical Research Coordinator (CRC) Assistant at ICON. This permanent opportunity, reports directly to the Clinical Operations Manager, with the primary aim; provide administrative support for executives. Independent judgment is required to plan, prioritize, and organize workload.

Our mission is to function as an Integrated Site Network, the role of our Coordinators are paramount to achieving our mission.

As a CRC Assistant, you will be responsible, day to day for the following tasks:

  • Develops and maintains knowledge and proper skills to comply with the protocol, federal regulatory requirements, internal SOP's and COG's
  • Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site
  • Proactively develops and executes recruitment plans that meet and exceed enrollment goals
  • Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
  • Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
  • Attends investigator meetings
  • Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines
  • Accurately collects study data via source documents/progress notes as required by the protocol
  • Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol
  • Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials
  • Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events
  • Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants
  • Dispenses study medication at the direction of the Investigator
  • Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits
  • Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor
  • Addresses all queries or data clarifications within the time period specified by the sponsor
  • Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in a timely manner during these visits
  • Reports protocol violations and significant deviations to the Manager of Clinical Operations
  • Establishes relationships with participants, and participates through ongoing patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process
  • Consistently communicates with investigators the status of patient referrals, overall recruitment status, and clinical needs of the study
  • Assists other staff members at the site as determined by the needs and priorities of the research organization and as time and abilities permit
  • Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement
  • Prepares study documentation in the event of an Accellacare, sponsor or FDA audit and assists the auditor for the duration of the audit including correcting discrepancies in a timely manner

Successful applicants will have the following:

  • 1 years' work experience in clinical research or pharmaceutical environment would be desirable
  • Life Science Degree
  • High level of attention to detail
  • Personable, able to build rapport with patients with ease
  • Motivated about a career in clinical research
  • Excellent planner, organized approach to work

What's Next?

Following your application, we will contact you and one of our dedicated recruiters will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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