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
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]
The employee will perform the job in an office environment, or remotely.
- 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.
- 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.
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.
Interested parties please send your resume to
HR email:firstname.lastname@example.org, HR@innocubebio.com