Clinical Site Coordinator

Recruiter / Employer: PDC CRO
Contract: Permanent
Salary: Confidential
Status: Expired

Job description

  • Coordinates data and operational compliance activities on one or more studies to ensure successful delivery of the studies.
  • Ensures accurate and timely entry of all data in the CRF/data collection tool from the source data/ notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data.
  • Prepares and collates regulatory documents for submission, including but not limited to site staff CVs, credentials, EC details, etc.
  • Participates in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Contacts patients/ subjects to arrange and facilitation of their visits.
  • Maintains the ISF and study trackers as delegated.
  • Follows the QC process and checks that ICF’s are correctly completed.
  • Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
  • QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and assessed by a physician within the appropriate timelines and flags any out of range values.
  • Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
  • Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses, if applicable.
  • Timely coverage of all assigned trainings.
  • Completes the assigned activities as part of any Patient Support Programs (PSP)
  • Assists with archiving procedures if required.
  • Interprets and adheres to company SOPs and policies and assists with input during the review process.
  • Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.
  • Executes any activities in compliance with applicable SOPs, instructions, and principles.
  • Qualifications

    Education and Experience

    • University degree with life science background or equivalent and relevant formal academic/

    vocational qualification.

    • Previous experience that provides the knowledge, skills, and abilities to perform the job

    (comparable to at least 1 year)

    In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

    Knowledge, Skills and Abilities

    • Good knowledge and practical aspects of implementation of ICH-GCP guidelines.

    • Good working knowledge of Business English.

    • Ability to communicate information and ideas so others will understand; with the ability to

    listen to and understand information and ideas presented through spoken words and

    sentences.

    • Basic medical terminology knowledge.

    • Good time management and multitasking skills to coordinate several studies simultaneously

    • Ability to access and use a variety of computer software developed both in-house and off-theshelf.

    • Appropriate MS Office Skills.

    • Good attention to detail.

    • May interact with others, relating and gathering sensitive information. Interaction includes

    diverse groups.

    • Works with guidance or reliance on oral or written instructions from management. May

    require periods of intense concentration.

    • Ability to perform under stress.

    • Regular and consistent attendance.

    Working Conditions and Environment

    • Work is performed in an office/ site-office environment with exposure to electrical office

    equipment.

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