Job Description
We are seeking a highly organized and detail-oriented Clinical Trial Assistant to join our clinical operations team in Rockville, MD. The Clinical Trial Assistant will play a pivotal role in supporting clinical trial activities, including supply tracking, trial master file maintenance, site invoice processing, query reporting, and subject tracking.
ResponsibilitiesSupport site initiation, monitoring, and close-out visits as needed.Maintain effective communication with clinical sites to resolve operational issues.Support subject enrollment and tracking activities across all trial sites.Assist with investigator and site staff training materials and logistics.Track and manage study supplies to ensure timely availability across clinical sites.Assist in the preparation, submission, and tracking of IRB/EC submissions and approvals.Maintain and update the Trial Master File (TMF) in compliance with regulatory requirements.Support audits and inspections by preparing documentation and responding to findings.Monitor data entry timelines and assist in resolving data discrepancies.Liaise with CROs, labs, and other third-party vendors.Collaborate with cross-functional teams to ensure efficient trial execution.Process clinical site invoices and assist with budget tracking.Organize internal and external study meetings, such as investigator meetings and DMC.Draft meeting agendas and take minutes to track action items.Essential SkillsSolid understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable FDA regulations.Strong attention to detail and organizational skills.Excellent verbal and written communication skills.Ability to manage multiple priorities and meet deadlines.Comfortable collaborating across cross-functional teams and with external partners.Additional Skills & QualificationsBachelor’s degree in a relevant field (e.g., Life Sciences, Nursing, Public Health, Pharmacy).Experience working in a healthcare or biotechnology setting.Familiarity with electronic data capture systems; experience with specific systems is a plus.Proficiency with Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).Understanding of Trial Master File (TMF) maintenance and clinical trial documentation practices.Work Environment
This position operates in an office environment. The team is small and collaborative, focusing on advanced oral drug delivery using precision immunotherapy. The new technology allows for delivering medicine through capsules, offering convenience for patients by avoiding IV infusion centers, particularly for the treatment of autoimmunity and cancer.
Pay and Benefits
The pay range for this position is $28.85 - $31.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Rockville,MD.
Application Deadline
This position is anticipated to close on Jul 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.