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Clinical Trials Project Manager

2 months ago

Bethesda, Maryland, United States Columbus Technologies Full time

Position Overview:

We are seeking a dedicated individual who is a US Citizen or Green Card Holder. This role is a W2 position that comes with comprehensive benefits.

Some travel may be necessary, and the offer is contingent upon successfully passing a background check and drug screening.

This position allows for some telework flexibility.

About Columbus Technologies and Services Inc.:
Columbus Technologies is a strategic partner to the federal government, providing essential services across various sectors. Through our collaboration with the National Institutes of Health, we offer professionals in administrative, IT, engineering, scientific, and healthcare fields the chance to contribute to one of the leading research institutions globally. We are currently looking for a Clinical Trials Project Manager to join our team.

Position Highlights:
This is a long-term opportunity that provides:

  • Competitive compensation
  • Significant growth potential
  • The chance to work at a premier medical research institution

Compensation:
The US base salary for this full-time role ranges from $52-60/hr, plus benefits. Salary ranges are determined by role, level, and location, with individual pay influenced by work location and other relevant factors.

Key Responsibilities:
The primary function of this role is to facilitate clinical research coordination and protocol management for the NINDS Intramural Research Program. Responsibilities include:

  • Assisting clinical staff in the development, implementation, and maintenance of clinical research data files and materials.
  • Collecting research data and preparing it for analysis.
  • Supporting the creation of forms and questionnaires.
  • Gathering data from patient records, interviews, and diagnostic tests.
  • Monitoring participant progress and reporting any adverse events.
  • Assisting in the assembly and review of new research projects.
  • Managing clinical websites and web-based tools.
  • Organizing and conducting clinical research using available resources.
  • Providing support to staff in the quality control of clinical research efforts.
  • Facilitating training for new research coordinators and mentoring researchers in Good Clinical Practices.

Qualifications:
Required Skills:
Bachelor's degree in biology or a health-related field.
Preferred Software:
Experience with Clinical Trial Management Systems (CTMS), Electronic Medical Records Systems, and Electronic Data Capture Systems.
Certifications:
ACRP Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), and Certified Clinical Research Associate (CCRA).

Experience:
Demonstrated experience in:

  • Overseeing and documenting investigational product dispensing and inventory.
  • Closing clinical trial sites upon completion.
  • Managing investigational product and trial materials.
  • Implementing clinical trial site action plans.
  • Training clinical trial site personnel.
  • Coordinating project meetings.
  • Conducting electronic medical records management.
  • Protocol review and revision.
  • Ensuring patient confidentiality and regulatory compliance.
  • Protocol development and writing.
  • Data monitoring and integrity.
  • Recruitment and scheduling of participants.

Diversity Commitment:
Columbus Technologies is an Equal Opportunity/Affirmative Action employer. We are committed to building a diverse workforce and welcome all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, age, national origin, veteran status, disability status, or any other protected class.

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