Clinical Trial Site Monitor

Location
Rockville, MD, United States
Posted
Jun 09, 2021
Ref
2021-9783
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Overview

We are currently searching for a Clinical Trial Site Monitor 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

  • Provide operational support to Contracting Officer's Representative (COR) for Division supported contracts providing clinical trial monitoring services in the context of domestic and international settings.
  • Assist in the development of tools and processes that will enhance effectiveness and efficiency to foster a robust clinical monitoring function.
  • Develop Protocol Specific Monitoring Plans tailored to specific human subject protection and data integrity risks of the trial.
  • Shadow monitoring visits to sites as necessary to assess compliance and potential monitoring challenges in the field.
  • Assist with developing work performance reports and follow the communications management plan for access by the program and relevant stakeholders.
  • Assist in identification of monitoring risks and risk owner and develop risk register and management plans.
  • Review and participate in drafting new procedures and work instructions for monitoring contract services.
  • Monitor and control clinical monitoring projects, scope, schedule and communications to ensure high quality deliverables.
  • Provide advice on clinical research operations and monitoring, regulatory affairs, GCP, or other related clinical research issues such as: a) review of site trend analyses or site monitoring reports; b) identification of concerns and solutions to site performance issues; and c) identifying opportunities for improving operations through site-specific training or site-specific visits.
  • May be responsible for oversight of a small portfolio of Clinical Research Sites (CRS) (Network and Non-Network). For these sites, serve as the day-to-day contact for CRS staff to facilitate clinical research site development, protocol implementation, and other operational and regulatory issues.
  • Advise Principal Investigators on clinical site start-up issues including resource allocation, personnel management and administrative issues. Sites may be Network affiliated sites or investigator-initiated project (Non-network) sites.
  • Direct and conduct formal evaluations of the CRS's organizational structures and modes of operation in relationship to the achievement of the Division's goals and objectives in the areas of administration, clinical site management and recruitment of participants.
  • Provide oversight and technical direction for evaluation of site performance using data compiled by Network/Non-network data management centers and other program contractors.
  • Assess the level of clinical research competency of CRSs and the extent of research knowledge and technology available to achieve the desired quality of operations at the clinical research sites.
  • Attend Network meetings, conference calls, ad hoc meetings and working groups as needed.
  • As needed, conduct trainings for sites and Network meeting participants on relevant policies and regulations.
  • Interface with program staff and with the Clinical Site and Study Monitoring (CSSM) contractor to support regular meetings related to task coordination.
  • Participate in working groups to provide technical expertise in development of new program policies and standard operating procedures (SOPs).
  • Plan and prepare communications for formal delivery to relevant stakeholders at programmatic and scientific meetings.


Requirements

  • M.S. in Health Science, Nursing Education or a related health field. A Bachelor's degree with three (3) years of specialized experience may be considered equivalent.
  • Minimum three (3) years of experience conducting study monitoring.
  • Experience advising on site evaluations and providing recommendations on courses of action.
  • Knowledge of clinical research operations, regulatory affairs, GCP and other related areas.
  • Excellent communication skills, both oral and written.

#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.