• KAI Research - Clinical Research Associate

    Location US-MD-Rockville
    # Positions
    Current Opening
  • Overview

    Support project teams in completion of commercial and government clinical research projects. Responsible for monitoring of all types of clinical trials.  Oversees the conduct of assigned clinical studies, including acting as liaison to clinical investigators and ensuring the quality and integrity of data.  Ensures the execution of clinical trials in a timely and efficient manner.  Adheres to Good Clinical Practices and compliance with all study procedures and federal regulations.   Coordinate clinical trial start-up activities and on-going active trial requirements.  Investigate problems and resolve or recommend solutions.


    • Monitor and coordinate all facets of the clinical trial process in accordance with FDA, ICH GCPs, local regulatory requirements and corporate SOPs.
    • Ensure timely and efficient execution of clinical trials and that sites are audit-ready at all times.
    • Monitor all aspects of a clinical trial from pre-study visits through the close-out visits to ensure study requirements are met and sites are compliant with the protocol, IP/device requirements and regulatory obligations.
    • Train investigators, coordinators and other site personnel on data collection methods and the protocol requirements.
    • Ensure completion of regulatory documents according to FDA regulations; reviews investigator responsibilities.
    • Assists in the planning and preparation of investigator meetings. Presents information and training at the meetings.
    • Develop client materials according to project requirements, including but not limited to, project-specific documentation, operating procedures, standards, and work flows.
    • Assist in the development of key monitoring deliverables such as clinical monitoring plans and report templates.
    • Oversee assigned clinical studies, including acting as liaison to clinical investigators, ensuring compliance with the protocols and the quality and integrity of data.
    • Review and verify the accuracy of the data on-site or remotely. Initiate action to resolve issues identified.
    • Reviews Adverse Event incidence, both serious and non-serious.
    • Ensures clinical supplies are properly stored and accounted for, and any necessary blinding is maintained.
    • Confirm the consent process is completed and documented appropriately and patient safety is maintained.
    • Reviews data query resolution.
    • Maintains regular telephone contact with site.
    • Performs in-house CRF review and query resolution as needed.
    • Performs medical and data quality review checks.
    • Ensures regulatory documents are available and current; ensures study material accountability, return and/or disposal as per protocol; reviews record retention requirements.
    • Assess IP accountability, dispensation and compliance.
    • Participate in clinical staff meetings, project team meetings, clinical training sessions, etc.
    • Maintains awareness of overall development in the field of clinical research, as well as assigned areas, by reading related literature, attending professional meetings, etc.


    • Bachelor’s degree in Science, Health, RN or BSN or equivalent experience in scientific or health care field plus 3-5 years health care or research related experience with a minimum of 2 years clinical monitoring experience.
    • Direct clinical trials experience and knowledge of procedures for monitoring clinical trials.
    • Sound knowledge of medical terminology.
    • Excellent written and verbal communication skills.
    • Good analytical and problem solving skills; detail-oriented.
    • Ability to work independently and work with a matrix team environment required.
    • Travel requirement for this position can range from 50-80%.



    KAI Research's dynamic work environment emphasizes integrity, personal commitment, and teamwork. In addition to the meaningful and challenging work, KAI offers an outstanding benefits program that includes paid time off, tuition reimbursement, 401k (5% employer contribution), a flexible work environment, and much more. We invite you to explore exciting and rewarding career opportunities with us. 


    KAI is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.


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