Overview
DRT Strategies delivers expert management consulting and information technology (IT) solutions to large federal agencies, the U.S. Navy, state and local government and commercial clients in health care, technology, and financial services industries.
The three letters of our name, DRT, stand for Driving Resolution Together, which is the core philosophy on which the company was founded. That is, we collaborate with our clients to solve their most pressing challenges - together.
We are problem solvers dedicated to your success, combining Fortune 500 experience with small business responsiveness. We have established a reputation with our clients as a forward-thinking consulting firm with demonstrated success in implementing solutions that lead to meaningful results. Our world-class consultants unite people to work collaboratively to achieve project goals and make vision a reality.
Project Description
The project supports applied regulatory science research and operational activities for the FDA Center for Drug Evaluation and Research (CDER). The outcomes of divisional research will be used to inform drug development and regulatory evaluation that supports the FDA’s mission to ensure that safe and effective drugs and biologics are available to the American people.
Job Summary
The Clinical Research Studies SME will provide administrative support for applied regulatory science research and operational activities in FDA. In addition, the SME will provide specialized expertise to improve business and knowledge management processes as well as other operational procedures.
Responsibilities
- Provide SME support to clinical research studies via the following activities-
- Coordinate with all stakeholders needed to execute a clinical research study including the FDA Institutional Review Board, FDA Human Subject Protection liaison, FDA study monitors, CRO(s), and external collaborators.
- Develop study budget estimates.
- Draft and/or review all required documentation: study protocol, informed consent form, statistical analysis plan, study specific SOPs (e.g., safety management plans), concept paper, final report.
- Support development and submission of study manuscripts.
- Support drafting of manuscript and supplemental materials, prepare figures and tables as needed, assist with journal submission and post-submission edits including responding to editor comments.
- Assist the project team to develop overall study tracking and management support by creating tools like trackers, activity checklists, and a SharePoint PowerBI dashboard.
- Capture processes in Manual of Procedures (MOP) document.
- Create a clinical team subsite to capture and provide easy access to all resources.
- Assist with overall project support as needed.
Require Experience:
- Demonstrate having the necessary skills and experience to manage and conduct complex and diverse research/development projects including pharmacokinetic study of oral, nasal and topical drug products to support FDA’s requirement.
- At least 3+ years of experience with toxicology studies.
Preferred Experience:
- Experience serving as a clinical study manager.
- Experience working in research setting leading to regulatory submissions for the FDA.
- Experience preparing drug applications in the pharmaceutical industry.
- Familiarity with FDA regulatory process.
- 5+ years of experience working in research or regulatory setting.
- Hands on experience working in a CRO.
- Familiarity with SharePoint and EndNote
- Familiarity with Section 508 compliance
Education & Training:
- Master’s degree (PhD preferred) in biomedical sciences.
Salary Range:
- $43-58/hr
- Salary commensurate with experience.
Company Benefits:
DRT offers full-time benefit eligible employees a competitive total compensation package. Employees may begin participating in employer sponsored group medical, dental, and vision coverage on their first day of employment. DRT also has a 401(K)-retirement plan, company paid short-term and long-term disability, life insurance, AD&D coverage, and an employee assistant program (EAP). Employees may also elect critical illness coverage, accident coverage, flexible spending accounts, and health saving account options. The DRT leave programs include Paid Time Off (PTO) each calendar year, paid holidays annually, paid parental leave, and unpaid job protected leave administered in accordance with the Family Medical Leave Act (FMLA).
EEO Commitment
DRT Strategies, Inc. (DRT) celebrates diversity and is proud to provide Equal Employment Opportunities (EEO) to all employees and qualified applicants for employment without regard to race, color, creed, religion, national origin, gender, sexual orientation, age, gender identity, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local laws.
Reasonable accommodation for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing [email protected], or by dialing 571-482-2517.
DRT Strategies, Inc. (DRT) follows the guidelines outlined by the Equal Employment Opportunity Commission (EEOC) to provide all employees and qualified applicants employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related conditions, transgender status, and sexual orientation), national origin, age, genetic information, disability, protected veteran status, or any other protected characteristic under federal, state, or local law.
Reasonable accommodations for applicants and employees with disabilities will be provided. If a reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Human Resources by emailing HR@drtstrategies.com, or by dialing 571-482-2517.
For additional information, please review the Know Your Rights: Workplace Discrimination is Illegal, E-Verify (English), E-Verify (Spanish). Right to Work (English), Right to Work (Spanish).
Please be aware of recruitment fraud where malicious individuals might pose as DRT Strategies. Only job postings and emails from drtstrategies.com are authentic and legitimate communications regarding DRT Strategies employment opportunities. Please contact Human Resources at hr@drtstrategies.com if you believe you have received a fraudulent email.
