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Clinical Trial Specialist #106967

Syneos Health Cambridge, MA
  • Expired: over a month ago. Applications are no longer accepted.

Job Title: Clinical Trial Specialist

  • Contract length: 12 month, renewable
  • Target Start date: 09/17/2019
  • Location: Cambridge, MA - office based
  • Full time work week (40 hours)
  • Medical/Dental benefits available

Duties:

· As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for study management and monitoring of assigned projects in accordance with Client SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines, local regulations and additional sponsor requirements.

· The CTS will participate in company, departmental and project team meetings.

· This position reports into Clinical Operations

· As a member of a global study team, the Clinical Trial Specialist (CTS) is responsible for study management and monitoring of assigned projects in accordance with Client SOPs, Good Clinical Practice, International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines, local regulations and additional sponsor requirements.

· The CTS will participate in company, departmental and project team meetings.

· This position reports into Clinical Operations

Summary of Key Responsibilities:

· Demonstrates study and clinical investigative site management according to Good Clinical Practices, ICH Guidelines, local regulations, and Client SOPs.

· Creates and provides input into study management requirements and tools, monitoring tools and manuals and training tools.

· Maintains thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.

· Performs study oversight and study site visits to ensure regulatory and study requirements are being fulfilled.

· Reviews study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches.

· Serves as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols;

· Provides input, tracks progress, and works to implement corrective action plans for study and individual site recruitment and retention plans.

· Develops and maintains collaborative relationships with investigational sites study teams, CRO teams, and vendor teams.

· Produces quality and timely study documentation, including trip reports, tracking and site/sponsor communications in accordance with standard operating procedures.

· Maintains accurate and timely Sponsor/site communication and correspondence.

· Responsible for ensuring IMP and supplies accountability.

· Participates in company, departmental and project team meetings.

Skills:

· 3 years monitoring / CRO management or CRO oversight experience of clinical trials, including site management, or equivalent.

· Knowledge of ICH GCP guidelines and the expertise to review and evaluate medical data.

· Excellent written and verbal communication, problem-solving, and interpersonal skills.

· Strong attention to detail.

· Effective organizational and time management skills.

· Ability to travel up to 35%

· Proficient with MS Office Suite (Excel, Word, and PowerPoint), familiar with MS Project

· Clear alignment with Client's Core Values (Commitment to People, Innovation and Discovery, Open Culture, Sense of Urgency, and Passion for Excellence)

Education:

· BS/BA degree required; degree in healthcare scientific field preferred.

Required Skills:

· SITE MANAGEMENT

· VENDOR MANAGEMENT

· ICH/GCP

· STUDY MONITORING

· CLINICAL STUDY MANAGEMENT

Syneos Health

Syneos Health is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life visit syneoshealth.com.

Address

Cambridge, MA
USA

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