Social & Scientific Systems (S-3)

Clinical Monitor

US-MD-Silver Spring
Job ID
2017-1676
Category
Clinical
Type
Regular Full-Time

Overview

Social & Scientific Systems (SSS) works to improve public health worldwide by providing technical, research, and program management services to government, nonprofit, and commercial clients. The SSS team offers a synergy of expertise in clinical research services, epidemiology and public health studies, health data management and analysis, and program evaluation and policy analysis. Please join our dedicated staff of employee-owners in an environment that values diversity and supports health, well-being, and professional growth.

 

 

Responsibilities

  • Assist in verifying qualifications and capabilities to successfully manage and conduct clinical trials in the CTC.
  • Serve as point of contact for investigative sites and supporting staff on assigned studies/projects for specific questions from both study monitors and/or study site personnel. Maintain documented telephone contact and written communication, per project requirements
  • Provide administrative and project/task coordination support to the site(s) and research study team(s), as assigned
  • Monitor activities at clinical study sites by conducting SQVs, SIVs, SMVs, and SCVs in accordance with company SOPs, network operation centers, study plans and protocol monitoring plans
  • Maintain a professional working relationship with all clients, investigators and clinical study sites. Professionally represents SSS to all parties.
  • Assist in the review and tracking of essential documents required for implementing, monitoring and evaluating clinical trials at assigned sites, per established guidelines
  • Remotely monitor investigator and clinical research site compliance through network operations or project plans with the established protocol, applicable Federal regulations, ICH-GCP and Institutional Review Board (IRB) requirements, with supervision
  • Remotely monitor the progress of clinical trials by verifying the accurate and complete collection/ recording of data on case report forms or database, with supervision
  • Review Adverse Event (AE)/Serious Adverse Event (SAE) reporting for compliance with the protocol, national and local regulations and established guidelines, with supervision
  • Reviews complete monitoring reports and related correspondence in a timely manner following each monitoring visit per the protocol-monitoring plan, or in support of network operations with few errors/edits needed and escalates issues appropriately.
  • Assist with review of SSS and investigator study files to ensure compliance with all applicable regulatory and client requirements
  • Maintain compliance with SSS policies and procedures, including security, safety and general workplace rules.
  • Keep abreast of ICH/GCP guidelines, SOPs related to clinical monitoring and current clinical developments in assigned therapeutic areas, independently
  • Participates in other related projects or activities as assigned

Qualifications

 

  • BS/BA in a life sciences program or field; nursing degree preferred, but not required
  • Minimum of 3 years of work experience in a clinical monitoring ; certification desired

Knowledge, Skills and Abilities:

  • Demonstrated initiative and ability to work with minimal supervision
  • Organizational skills with keen attention to detail
  • Effective communication skills (written and verbal) with the ability to communicate effectively with clinical site staff and research physicians
  • Team player with a strong customer focus and excellent interpersonal skills
  • Working knowledge of ICH/GCP guidelines, Federal regulations, medical terminology and clinical research processes
  • Basic computer skills and ability to learn and become proficient with appropriate software; working knowledge of Word, Excel, and PowerPoint.
  • Ability to utilize problem-solving techniques applicable to constantly changing environment




SSS is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

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