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Clinical Trials Manager

2 months ago

Newton, United States Boston Center for Memory Full time
Job Overview

The Clinical Trials Manager plays a crucial role in overseeing clinical research initiatives at the Boston Center for Memory (BCM). This position operates under the guidance of the Principal Investigator and collaborates with a diverse team of specialists in neuropsychology and neurology.

Key Responsibilities

The responsibilities of the Clinical Trials Manager include:

  • Executing daily research tasks in accordance with BCM's Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP) guidelines.
  • Updating and maintaining data collection instruments, spreadsheets, and databases essential for the compilation of research-specific information.
  • Managing the clinical trial initiation process, including protocol receipt, IRB submissions, and site activation.
  • Identifying and recruiting eligible study participants.
  • Coordinating visits with sponsors and study monitors, and facilitating the initiation of clinical trials.
  • Scheduling necessary tests and treatments as outlined in the protocol, while preparing and maintaining regulatory documents for the IRB and sponsors.
  • Overseeing data management and reporting, including the collection of source documents, development of case report forms, adverse event reporting, and resolution of data queries.
  • Assisting in the completion of studies, data lock, and overall study closeout processes.
Required Skills and Competencies

The ideal candidate will possess:

  • Exceptional organizational, written, and verbal communication skills.
  • The ability to manage multiple tasks effectively along with strong time management capabilities.
  • Robust interpersonal skills, enabling effective interaction with all levels of staff.
  • The capability to work independently as well as collaboratively within a team.
Education and Experience Requirements

Applicants should have:

  • A minimum of a bachelor's degree, nursing qualification, or substantial experience in research coordination.
  • Preferred experience in industry clinical trials.

This full-time role offers a competitive salary and benefits package.

About Boston Center for Memory

Boston Center for Memory is dedicated to enhancing the lives of patients and their families through education, multi-specialty treatment approaches, and ongoing care. Our mission includes conducting research aimed at improving diagnostic methods and developing better treatment options for individuals with Mild Cognitive Impairment, Alzheimer's disease, and related dementias.