Medical Assistant

Medical Assistant

Requirements

• High school diploma or equivalent; Bachelors degree preferred
• Completion of an accredited Medical Assistant program and current certification as a Certified Medical Assistant (CMA) or Registered Medical Assistant (RMA)
• Basic Life Support (BLS) required or willing to obtain within 30 days of hire
• Previous experience in a clinical or research setting is highly desirable
• Proficiency in electronic source documentation (e-Source) and electronic Investigator Site File (eISF) systems is desirable
• Proficient in Microsoft Office applications
• Strong organizational skills, the ability to effectively prioritize tasks and attention to detail
• Ability to work collaboratively in a multidisciplinary team environment
• Ability to effectively communicate with suppliers and key stakeholders in a professional and constructive manner
• Strong interpersonal skills –ability to work well in a multi-cultural environment and matrix organization
• Service oriented (External and Internal)
• Flexible and adaptable

Responsibilities

• Adherence to Good Clinical Practice (GCP) guidelines, Institutional Review Board (IRB) requirements, and Standard Operating Procedures (SOPs)
• Obtain and record vital signs, medical histories, and other relevant patient information
• Collect, process, and prepare shipment of laboratory specimens according to IATA requirements
• Perform basic CLIA-waived and Point of Care (POC) laboratory tests, such as urinalysis and blood glucose testing
• Prepare and administer medications and vaccinations as directed and appropriately delegated by a physician or other licensed provider
• Prepare and maintain examination rooms, ensuring all necessary equipment and supplies are available
• Maintain clinical site supply and equipment inventory
• Assist clinical team during medical procedures and direct participant care
• Operate and support maintenance of medical equipment (i.e. electrocardiogram (ECG) and centrifuge)
• Maintain cleanliness and sterilization of work environment
• Support the planning, execution, and close out of clinical trials
• Schedule participant appointments and manage participant flow including the site’s clinical calendar
• Manage front desk including check in/check out of participants as required
• Assist in participant recruitment and retention initiatives, including but not limited to calling potential participants, conducting pre-screening questionnaires and participation in community events
• Assist with patient education responsibilities including but not limited to helping participants understand study procedures, expectations, compliance with protocol, and follow-ups
• Maintain accurate and up-to-date patient records, including data entry into electronic source or system
• Ensure temperature logs and supply expiration tracking are maintained for regulatory compliance
• Handle patient correspondence, escalating to relevant clinical team members as required
• Manage patient payments via electronic means
• Completes essential training such as GCP, HIPAA, IATA, and other training deemed necessary
• Completes necessary study related training, as needed
• Assists with eISF filing on an as needed basis
• Ensure compliance with all regulatory and study-specific requirements
• Ensure data entry accuracy and answer and resolve queries in timely manner
• Compliance with GDP, ACLOA+, and assists CRC in all aspects of data collection and review, not limited to QC of data
• Participate in monitoring visits, audits, and inspections by regulatory agencies or sponsors
• Regular and reliable attendance with the ability to work after hours/weekends as needed as well as rotating on-call shifts that may include weeknights, weekends, and holidays
• Any other duties as needed.

Preferred Qualifications

• Previous experience in a clinical or research setting is highly desirable
• Proficiency in electronic source documentation (e-Source) and electronic Investigator Site File (eISF) systems is desirable