Clinical Trial Site Manager

Location
Rockville, MD, United States
Posted
Jun 09, 2021
Ref
2021-9782
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Overview

We are currently searching for a Clinical Trial Site Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD.

Duties & Responsibilities

  • Oversee and track the status of site activation and reactivation requirements.
  • Oversee CRO performing site activation and site management requirements for fast-paced COVID-19 studies.
  • Triage questions and issues from CRO to protocol team leadership.
  • Summarize, analyze and present site activation and reactivation status indicators for NIH and/or protocol team leadership.
  • Summarize, analyze and present site performance metrics for NIH and/or protocol team leadership.
  • Develop and/or coordinate training materials for CRO staff on implementation or management of protocol.
  • Develop processes for managing the CRO implementation of site activation and site performance of clinical research sites.
  • Implement and coordinate a range of individual clinical site-management activities.
  • Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, personnel management, and administrative issues.
  • Provide leadership for planning, organizing, and conducting site visits or reverse site visits to clinical trials units to effectively fulfill site management responsibilities.
  • Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality of the clinical trials units.
  • Direct and conduct formal evaluations of the clinical research sites' organizational structures and modes of operations in relationship to the achievement of the Division's goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
  • Provide oversight and technical direction for evaluation of site performance using data compiled by the network data management centers.
  • Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to Leadership.
  • Conduct trainings at sites and Network meetings on relevant policies/regulations.
  • Attend Network meetings, conference calls, ad hoc meetings and working groups.
  • Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing training manuals, policies and procedures.
  • Participate in the creation and review of study or site closure-related documents and checklists
  • Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
  • Prepare oral and written presentations for internal and external programmatic and scientific meetings


Requirements

  • Master's degree in Nursing Education or a related health or scientific field. A Bachelor's degree plus three (3) years of specialized experience may be considered equivalent.
  • Experience activating clinical trial sites required.
  • Experience conducting site evaluations and providing recommendations on courses of action.
  • In-depth knowledge of clinical research operations, regulatory affairs, GCP and areas related to clinical site start-ups.
  • Excellent verbal and written communication skills.

#LI-DW1

Company Description

We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.

The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.

What you'll get...
  • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
  • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
  • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
  • Discovery! With our tuition assistance and training programs, we support your career advancement.
  • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
  • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
  • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
  • A Voice! A unique culture where you can influence decisions and have your voice heard.


We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.