MPF Federal is seeking a Research Specialist to support project teams in completion of commercial and government clinical research projects. Perform duties with supervision by clinical research managers and project managers. May manage portions of projects under supervision of more experienced research staff. Create, review, and maintain project documentation according to project requirements. Coordinate clinical trial start-up activities and on-going active trial requirements. Investigate problems and resolve or recommend solutions. Coordinate with clients, sponsors, and site personnel to ensure project needs are met.

COMPENSATION: $55,000.00 - $65,000.00 Annually

This position is remote; however, the person should reside in the Bethesda, MD area.

Essential Duties:

Demonstrate a thorough understanding of the application of basic clinical research methodologies to meet protocol and regulatory requirements.
Develop client materials according to project requirements, including but not limited to, project-specific documentation, operating procedures, standards, and work flows. Monitor project changes to ensure documentation and systems/software conforms to new requirements.
Process incoming and outgoing project materials to monitor, verify, and track receipt of documentation and ensures appropriate distribution of materials to internal and external research personnel and sites.
Execute assigned portions of clinical studies. Carry out activities while optimizing efficiency, quality and consistency, while maintaining compliance with SOPs, policies and procedures.
Coordinate the activities of smaller, well-defined projects.
Communicate with clients, sponsors, and site personnel to ensure project needs are met.
Compile data, track, analyze and prepare reports including project status, project summaries, and recommendations. Support data management activities. Work with clients and internal subject matter experts to develop database specifications. Document specifications and obtain approvals. Perform data management activities as needed.
Prepare general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensure review, approval, and distribution to internal staff and external project participants.
Provide logistical support for committee meetings and DSMB meetings, including planning, arrangements, travel and post-meeting activities and writing reports.
Design build, and update spreadsheets and other tracking tools.
Recognize which decisions may have a consequential effect on the Project and make decisions based on experience, skill, and situation, consulting with and/or informing others as appropriate.
Maintain clinical research files and related documents.
Demonstrate a thorough understanding of company policies, procedures, and standards.
Ensure work is completed on time and is of the highest quality.
Perform related duties as assigned.

Requirements

Bachelor's degree in science, health, or related field. Master's degree preferred.
Two or more years of relevant experience. Previous experience within a pharmaceutical company, CRO, clinical site or within NIH is desirable.
Familiarity with FDA and GCP regulations required.
Knowledge of Microsoft Office tools such as Word, Excel, and PowerPoint. Experience using data management systems preferred.
Must be comfortable working in fast-paced environment and managing a heavy workload and multiple projects with competing priorities, with the ability to switch priorities quickly as needs change.
Exceptional interpersonal skills and written and verbal communication skills.
Good decision-making and problem-solving skills.
Strong organizational skills; accurate and detail-oriented.
Demonstrated technical skill and expertise as it pertains to clinical research support

Benefits

MPF Federal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. We offer a competitive compensation package including a competitive salary, medical benefits, PTO, holiday pay and more.

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