Clinical Trial Assistant
U.S | 1 | BS/BA degree or equivalent |
Position Responsibilities/Major Duties
  • Assist the Study Manager in training CRO CRAs and creating the CRA training material
  • Attend co-monitoring visits as required per the Sponsor Oversight Plan and/or Monitoring Plan or as needed
  • Review Monitoring Visit Reports from the CRO
  • Monitor studies (PSV, SW, IMV, COV) as needed
  • Escalate monitoring trends or findings to the Clinical Operations Directors
  • Track metrics related to Sponsor Oversight and the Monitoring Plan
  • Provide overall tactical support for the study
  • Provide administrative support, as needed, for one or more studies
  • Identify and resolve project administration issues
  • Lead or assist with TMF processes: set-up, training, QC, management
  • Collaborate with CRO counterpart
  • Provide study support and systems management
  • Proactively identify and solve study-related issues
  • Track clinical supply shipments and manage shipment logistics
  • Participate in IM planning and conduct
  • Coordinate vendor face to face meetings
  • Provide documentation for CSR appendices
  • Provide monthly site activation updates to Regulatory for routine IND submission updates
  • Track/manage translations of recruitment materials and questionnaires
  • Obtain questionnaire/scale licenses with support from Study Manager
  • Ensure studies are compliant SOPs, ICH, Global Regulations, Ethics and Compliance
  • Risk Based remote monitoring through listings and data dumps

Supervisory Responsibility:

This position has no supervisory responsibilities.



Travel may be required to visit the parent company, customers, related organizations in US. China and elsewhere. etc., about 60%.


Direct Report to: [Director, Clinical Operations]


Work Environment:

The employee will perform the job in an office environment, or remotely.


Physical Demands:

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Regular sitting for extended periods of time.
Job requirements

Required Technology:

  • Strong MS Excel, Word, and PowerPoint skills
  • Strong problem-solving skills and attention to details


Required Education and Experience:

  • BS/BA degree or equivalent and 2+ years experience in clinical development
  • On-site monitoring experience conducting SIVs, IMVs, and COVs highly desired
  • Co-monitoring experience desired
  • This role will require some travel — ranging from 10% - 60% during peak study activity
  • Strong communication and interpersonal/team skills
  • Proficient in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines.
  • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a quick-changing, fast-paced environment, excellent people skills, and a proven record as a team player.



  • Able to identify and resolve key issues.
  • Highly accountable.


Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.


Contact E-mail:

Interested parties please send your resume to