• 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:

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.

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.

Qualifications:

• 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

HR email:lpswhr@lepubiopharma.com, HR@innocubebio.com