Ref #: 30181

Employment type: Permanent - Full-Time

Location: United States-RTP, NC, North Wales, PA or Brentwood, TN

Posted: 23-Jun-2021


DOCS is currently seeking an experienced Clinical Trial Specialist for an opportunity based in RTP, NC, North Wales, PA or Brentwood, TN

• Contribute to the preparation of training materials (Investigator Meetings, Site Evaluation and Initiation Training)
• Manage process for planning and procuring ancillary clinical supplies
• Facilitate and collate country recruitment plans
• Create and manage study specific tools such as recruitment and retention materials and study newsletters
• Maintain study level storyboard
• Facilitate authoring of Investigational Product Information Manual (IPIM) and study specific Important Protocol Deviation (IPD) list
• Compile IRB/EC submission documentation
• Assist with Global Development Operations (GDO) Operational Review preparation
• Prepare Clinical Study Team (CST) meeting agendas and minutes
• Manage global versioning and distribution of informed consent forms (ICFs)
• Facilitate cross functional meetings
• Submit documents to trial master file (TMF) in EPIC

• Ability to understand technical, scientific and medical information
• Understanding of drug development process
• Familiar with advanced concepts of clinical research
• Advanced computer skills
• Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
• Ability to write and present clearly using scientific and clinical issues terminology
• Experience dealing with time demands, incomplete information or unexpected events
• Good organizational and planning skills
• Experience working effectively in a team/matrix environment

Basic qualifications
• BA/BS/BSc or RN
• Specialist experience working in life sciences or medically related field
• Previous biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)

Preferred qualifications
• BA/BS/BSc in the sciences or RN

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

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