Clinical Operations Coordinator - Houston, TX | Biospace
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Clinical Operations Coordinator

Cell Medica

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Location:
Houston, TX
Posted Date:
8/31/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Associates Degree
Areas of Expertise Desired:
Clinical Operations,

Job Description


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.

Requirements


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