Clinical Protocol Specialist

Location
Frederick, MD
Posted
Sep 05, 2017
Closes
Sep 06, 2017
Function
Other
Industry
Science
Hours
Full Time
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO). Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research. Emmes is seeking a Clinical Protocol Specialist to support all phases of clinical trials.

PRIMARY PURPOSE

The Clinical Protocol Specialist is responsible for the operational support activities for a protocol or group of protocols, monitoring study timelines and the clinical research studies at external trial sites. In addition, the Protocol Specialist works closely with internal project members to ensure compliance with regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), the study protocol and overall research objectives.

PRIMARY RESPONSIBILITIES INCLUDE

  • Possesses detailed knowledge of the protocol and its associated activities and timelines
  • Participates in the preparation and/or review of protocol and informed consent documents
  • Collaborates with the project team and other study personnel to determine data collection requirements based on the study protocol
  • Designs and develops electronic case report forms (eCRFs)
  • Reviews, contributes to, and processes project documents and required reports, such as SAE and protocol deviation reports, accrual and other study status and/or study web site reports
  • Contributes to project-specific site initiation activities, tracks readiness status of sites for study initiation (e.g., submission of essential documents, writes and distributes corresponding internal reports)
  • Writes and distributes site initiation/activation reports within established timelines, and tracks resolution of outstanding issues
  • Collects, reviews and maintains regulatory documents
  • Review includes assessment of completeness and compliance with regulatory requirements
  • Prepares and reviews study and project materials, (e.g., Manual of Operating Procedures (MOPs), Site Monitoring Plans, and SOPs)
  • Demonstrates understanding of project and corporate SOPs by producing work in compliance with the SOPs
  • Maintains documentation required by corporate and project SOPs
  • Conducts training sessions for site personnel on GCP, and study protocol requirements
  • Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT), project SOP and Compliance/Variance table development, participation of internal and external audits, and professional development activities
  • Reviews and contributes to project-required reports (e.g., contract reports)
  • Attends and participates in project and functional group meetings and in continuing education activities
  • Participates in conference calls, prepares agendas and summaries, as needed
  • Prepares scientific minutes for external distribution
  • Establishes and maintains effective working relationships with internal and external study personnel

EXPERIENCE, COMPETENCIES AND EDUCATION

  • Bachelor’s degree in a scientific discipline
  • Experience in clinical research preferred.
  • Skills in prioritization, problem solving, organization, decision-making, time management, and planning
  • Self-motivated and detail-oriented
  • Excellent oral, written and interpersonal communication skills
  • Ability to work independently, as well as in a complex team environment
  • Ability to travel as required by project

Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs.

CONNECT WITH US!!
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Find us on LinkedIn - The EMMES Corporation

Emmes is proud to be an Equal Opportunity Employer EOE/M/F/D/V

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