Clinical Protocol Coordinator
We are currently searching for a Clinical Protocol Coordinator 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 Bethesda, MD.
Duties & Responsibilities
- Attend internal/external meetings with staff specifically related to Clinic and work on issues that impact including but not limited to roster issues, DCTD-Audit.
- Information System (AIS) business rules and enhancements, and other issues pertaining to Clinic.
- Work with the auditing units, nursing staff and medical records to support audits; collate audit response.
- Prepare standard operating procedures (SOP) for audit.
- Attend calls with multicenter sites and prepare notes documenting the communication.
- Work with nursing staff and data managers to answer queries from Theradex; prepare written responses.
- Collaborate with staff on the preparation of regulatory documents as required for protocol approval by FDA, CTEP, IRB, OPRR and drug sponsor.
- Maintain accuracy of data files via multiple software systems, including computerized procurement reports and communication programs.
- Update and maintain regulatory binders.
- Master’s degree in a life science related discipline and a minimum of four (4) years of related experience.
- Ability to anticipate staff needs in the varied avenues of research, analysis, and reporting, and create alternative processes for addressing tasks where appropriate.
- Excellent analytical, organizational and time management skills.
- Strong communications skills, both oral and written.
- Ability to adapt and create tools to analyze and evaluate projects.
- Background in clinical trials quality assurance and monitoring.
- Software: MS Office Suite, Clinical Trial Management System (CTMS), Electronic Medical Records System, Electronic Data Capture System
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.