To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Verify correctness and completeness of ALL source documentation
Ensure errors on source documents and timeously (within 24hours) corrected, initialled, and dated by the authorized signatory
Assist in completion of corrective action for internal monitoring reviews - coordinate staff training (and retraining) where error trends are identified
Assist with the review and revision of standard operating procedures per study specific needs as needed
Assist in electronic data clarification queries
Perform 100% QC of all ICF documentation and maintain tracking log
Resolve laboratory errors by timeously generating or responding to DCFs
Review and verify CRF’s and source documentation to ensure accuracy and completeness and compliance with applicable regulations.
Identify trends of inconsistencies and deviations to the requirements and regulations listed above.
Document findings relating to the monitoring of CRF’s and source documents and disseminate these findings to the appropriate clinical staff.
Ensure that monitoring reports are returned timeously and include adequate documentation that findings have been resolved appropriately.
Assist in reviewing specified records prior to site audits by external monitors or inspections by other regulatory bodies.
Review Site Monitoring Reports generated by external monitors to assist in identifying trends and errors in completing CRF’s and source documents and apply this knowledge to improve subsequent monitoring.
Ensure site readiness for new protocols
Develop tools and source documents to ensure protocols are adhered to and smooth collection of required data.
Develop and review essential study specific documents (e.g.: SOPs, Protocol, source documentation and lab forms).
Produce relevant weekly reports according to project needs
Support the ordering and control of consumable stock
Support inventory and calibration of clinical equipment
Timely reporting of study statistics to the study PI and team.
Assist with efficient clinic flow activities
Take ownership and accountability for tasks and demonstrates effective self management.
Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained.
Maintain a positive attitude and respond openly to feedback.
Take ownership for driving own career development by participating in ongoing training and development activities such as conferences, workshops etc.
Able to work independently and as part of a team, confident to lead study QA activities from start-up to closure.
Organizational skills, Interpersonal skills, data collection and Computer skills Good writing skills , good Communication Skills Highly Motivated , Result Driven Attention to detail Analytical skills Ability to work individually Ability to work in teams, ability to work under pressure, Stress tolerant , good attention to detail, Interviewing skills, Source Data Verification(SDV) ,Training , ,Regulatory Compliance, Monitoring Report Writing ,Clinical Data Management
I take up exercising as a way to alleviate stress. And cooking and Baking to make my daughter happy.