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Job Title: Clinical
Operations Coordinator

Responsible to: Head
of Clinical Operations

Role

Supports the Clinical and Medical Affairs Departments in a
global capacity by assisting in the administrative organization and management
of projects ensuring compliance with SOPs, Sponsor and ICH-GCP/ISO14155
requirements. This position also involves general office administration tasks.
The role involves high utilization of PC based software packages for word
processing, spreadsheets, and graphics. Position is full time and office based
in Houston, Texas.

Responsibilities

  • Manage administrative support and tasks for the clinical and
    medical teams, including but not limited to filing, faxing, memos, letters and
    photocopying support for designated project team(s), as required.

  • Create and maintain study files, including Trial Master File
    according to SOPs.

  • Attend project team meetings, prepare meeting agendas and
    minutes, and maintain action item lists from meetings.

  • Prepare study documents and manage version control at the
    direction and oversight of the clinical, medical or regulatory staff.

  • Route contracts and other documents for review and/or
    signatures, as required.

  • Provide logistical support and tracking of clinical trial
    samples for both domestic/international shipments.

  • Assist external users with file/data uploads to a
    centralized cloud based platform.

  • Maintain study trackers and contact lists, supporting other
    staff as required.

  • Distribute study materials to investigator sites and team
    members, as required.

  • Assist in preparation for investigator meetings, conferences
    and international study committee meetings.

  • Support of medical affairs activities including:

  • Literature searches and electronic library maintenance

  • Key opinion leader identification and mapping

  • Logistical support for medical affairs activities (meeting
    scheduling, etc)

  • Making travel arrangements and processing expense reports,
    as required.

  • Performs other project or work-related duties, as assigned.

Education and Experience

  • Associate or Bachelors’ degree (BS, BA, or RN equivalent) in a biological or science-related field preferred.

  • At least 5 years administrative experience in the Biotech
    industry or other healthcare field.

  • Advanced computer skills in MS Office Suite, including Word,
    Excel, PowerPoint and Adobe Acrobat are necessary, document management, Share
    Point and eTMF a plus.

Personal Attributes

  • Team and service oriented

  • Highly organized

  • Dependable and meet commitments

  • Quality and detail oriented with high standards

  • Strong planning and organizational skills, verbal, written

  • Well-developed communication skills, good at listening and
    sharing information with others

  • Ability to act on own initiative within inter-related team
    communication

  • Adaptable and comfortable with change or uncertainty

  • Must be able to remain in a stationary position 50%

  • Constantly operates a computer and other office productivity
    machinery, such as a calculator, copy machine, and computer printer

  • Fluent verbal and written English language is essential
  • Must be able to remain in a stationary position 80%

  • Constantly
    operates a computer and other office productivity machinery, such as a
    calculator, copy machine, and computer printer.

This
job description is subject to change at any time


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