• 7 years of Regional home-based monitoring experience
• 9.5 years of Clinical Research experience
• Current Workload: 3 Oncology studies (I-III) with 12 sites
• Proficient with various EDC systems (Medidata RAVE, Merge eClinicalOS, and Inform)
• Proficient with Microsoft Office (Word, Excel, Power point, OneNote, Outlook)
• Proficient with CTMS (Impact Harmony, OnPoint, and Trial Tracker)
• Knowledgeable of RECIST measurement criteria for solid tumors
(Contract: H&P Clinical Consultants)
Conduct study initiation visit along with routine monitoring and closeout visits to ensure the Principal Investigator and other site personnel understand their duties related to the clinical trial protocol.
Assist in the development of patient recruitment strategies.
Assist in mentoring junior staff.
Maintain study metrics for reporting purposes through established clinical study dashboards and trackers; with archiving reports.
Ensure all site personnel have appropriate EDC and IVRS access.
Provide input into the design of protocols, CRFs and monitoring plans as requested.
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
Complete monitoring reports and follows up to ensure project timelines were accomplished on schedule.
Ensure data collection and drug accountability in accordance with ICH- GCP guideline.
Assist with the management of study supplies and organize shipments.
Work with study team to resolve clinical and/or protocol issues.
(Contract: H&P Clinical Consultants)
Performed all clinical monitoring /site management activities for assigned protocols in accordance with Worldwide SOPs.
Actively communicated with study sites as needed and provided support to the Study Coordinators.
Verified that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.
Oversee IRB/IEC submission document collection and other supplementary documentation as appropriate.
Ensured all adverse events, concomitant medications, and inter-current illness are reported in accordance with the protocol on the CRF.
Assisted in query generation and resolution in the electronic database.
Tracked and maintained study information and reports on study process.
Maintained and ensured all documentation is in a state of audit readiness.
Coordinated study logistics, documents, drug shipments, enrolment and safety.
Developed, conducted, and facilitated research protocols.
Coordinated study visits and procedures, including specimen acquisition, transport, documentation, and shipment.
Assisted in the development and completion of source documents and case report forms.
Completed Institutional Review Board preparation, submission, modifications, reporting, and termination activities.
Obtained informed consent by following policy, procedure, and regulatory requirements.
Monitored compliance throughout all study activities and engages compliance oversight as needed.
Supported Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation.
Participated in educational activities related to study needs for study staff, investigator team, and patient care staff.
Receives patient specimens and performs specimen accessioning.
Performs actual patient testing and quality control in assigned areas as necessary.
Maintains ranges, specimen requirements for tests, and acceptance criteria.
Maintains and adheres to approved procedures and quality assurance measures.
Performs scheduled maintenance, corrective actions, and troubleshooting to assure result quality and performance efficiency through the maintaining of written records.
Prepares and maintains monthly quality control reports.
Performs pre-analytical checks and works closely with client services team to manage and resolve pre-analytical errors
Participates in training and validation of tests.
Prepares reagents, organizes, and maintains inventory of supplies.
Maintains safe and clean working environment by complying with procedures, rules, and regulations.
Maintains records, maintenance and inventory logs.
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