Computer Technologies Consultants (CTC) is seeking a Post Approval Compliance Monitor to support the Defense Health Agency (DHA) in Silver Spring, MD.
With offices in Washington DC and San Diego, CA, CTC is a leading technology company providing lifecycle IT, data analytics, cloud managed hosting services, agile software development, DevOps, Test Automation, Cyber Security, and infrastructure solutions. Additionally, we provide Professional Talent Acquisition Services as we proudly support the unique needs of U.S. Defense, Intelligence, and Federal Civilian agencies as well as Fortune 1000 companies.
Got the Government Contractor Blues? Looking for a company that cares and goes beyond just filling another contract billet? Well look no further. Experience this family-oriented company who takes pride in you and will help you grow where your passions lie. Holding many Defense & Federal government contracts around the globe, with our client you have the opportunity to take on new and evolving challenges, aim beyond what you think you are capable of and work in collaborative, dynamic, and high-tempo environments. Our clients' employees are their most valued asset and they invest in their people because they are in it for the long term. They are committed to your success and well-being and offer competitive benefits packages, salaries, bonus/award programs, and a high potential for professional growth and job opportunities world-wide.
Why Should You Be Interested Direct hire full-time position Competitive base salary and comprehensive benefits Mid-size company with room for growth Position Title: Post Approval Compliance Monitor
Position Location: This position is full time onsite in Silver Spring, MD with regular task-related off-site travel
Daily Responsibilities:
- Conduct clinical research scientific monitoring services to verify that ongoing research is conducted in accordance with existing regulations, policies, and procedures to include providing training as needed/requested.
- Develop a monitoring plan that includes a schedule for the conduct of routine monitoring for the client and its forward laboratories in accordance with applicable SOPs. The monitoring plan shall be delivered within three months of Task Order award and updated annually.
- Perform routine and for-cause monitoring of human subjects research and protocols that receive research determinations. Verify the appropriate regulations are applied during the review of a study and validate that the research/activity is conducted as approved. Perform monitoring visits considered to be time sensitive within timeframe specified by COR.
- For each monitoring visit, draft reports that accurately document the conduct of monitoring activities performed and corrective actions requested/performed by the study team.
- Perform weekly internal reviews of hard copy and electronic HSPB files. Update/correct files, as necessary, within five business days of identification of an error.
- Conduct training in human subjects protection, compliance monitoring, and quality of records to investigators, client researchers, IRB, and other staff as needed.
Required Years of Experience (min):
Required Education: - MS, RN, or other science degree preferred
Required Experience:
- 5-10+ years of experience in monitoring clinical and social behavioral research.
- CCRA preferred.
- DoD experience preferred.
- Intermediate to advanced skills using Microsoft Outlook, Word, PowerPoint, and Excel.
- Strong verbal and written communication skills.
- Experience conducting trainings in human subjects protection, compliance monitoring, and quality of records.
- Strong organizational and time management skills.
Required Clearance:
- U.S. citizenship required.
- Candidates must be able to secure and maintain Federal Government security clearances as deemed appropriate by management
Pay Information Full-Time Salary Range: TBD
Please note: This range is based on our market pay structures. However, individual salaries are determined by a variety of factors including, but not limited to: business considerations, local market conditions, and internal equity, as well as candidate qualifications, such as skills, education, and experience.
Computer Technologies Consultants, Inc. is an Equal Opportunity Employer that provides employment opportunities for all qualified applicants without regard to race, color, religion, gender identity and/or expression, sexual orientation, age, mental or sensory differing abilities, protected veteran status, sex, national origin, or any other characteristic protected by applicable law. Computer Technologies Consultants, Inc. is devoted to diversity, equity, and inclusion.