SUMMARY

• 9.5+ years of experience in Clinical Research Profession. Started as Clinical Research Associate, Lead CRA and Clinical Team Manager leading large global / multinational studies across different regions.
• Experience working in various therapeutic areas like Rheumatology, Oncology, Infectious diseases, endocrinology, respiratory diseases, and cardiovascular diseases.
• Has also been involved with training and mentoring of staff in all instances related to clinical operations.

PROFESSIONAL EXPERIENCE

Confidential, Miami - FL

Lead, Clinical

Responsibilities:

• Project Team: 3 CRAs and 01 CTA
• Function as CTM for US and International projects
• Negotiate Master Service Agreements, Clinical Trial Agreements, and Change Orders
• Allocate CRA resources across clinical studies, perform co-monitoring / quality visits with CRAs
• Prepare study specific plans like - monitoring, communication, central filing, safety, data management and CRF review
• Identification and selection of investigator sites.
• Ensure projects are managed within contracted schedules and budgets while coordinating properly
• trained resources
• Manage various vendors to support clinical trials projects that the CRO is involved in accordance with company goals, objectives, policies and procedures
• Ongoing training of the study team
• Perform pre-study, initiation, regular monitoring and closeout visits if needed

Confidential

Clinical Team Manager

Responsibilities:

• Project Team: Managed team of 04 to 14 CRAs across different regions.
• Project Management - Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial
• Planning - Prepare Project Management Plan and provide training to ensure consistent study / project practice throughout trial
• Resource Management - Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables
• Financial Risk - Manage clinical budget (site contracts); escalate out of scope activities to the appropriate individuals for inclusion in a contract modification
• Data Analytics - Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to external/internal clients/vendors
• Risk Management - Manage contingency planning for data cleaning; clinical data listings review; and, coordinate process for reviewing data listings by a clinical team
• Provide leadership, coordination, and management of the project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities
• Prepare study specific plans but not limited to safety, data management, monitoring, training, risk management and filing.

Confidential

Senior Clinical Research Associate

Responsibilities:

• Regional Project Manager
• Repreenting APAC region for revising corporate training development program
• Assisted clinical study team for the preparation of EMEA Inspection
• Assist in investigator study site selection and study start-up
• Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines
• Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.
• Performed Site Selection Visits - 18, Site Initiation Visits - 20, Routine Monitoring Visits - 70 - 80, Site Close out visits - 15 and Co-monitoring visits - 15

Confidential

Clinical Research Associate

Responsibilities:

• CRA for Rheumatoid Arthritis, Allergic Rhinits, Astham, COPD and Osteoporosis study
• Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulations and ICH guidelines.
• Regularly provide the clinical status information to team members and project management.
• Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results.
• Perform site contracts negotiations
• Performed Site Selection Visits - 25, Site Initiation Visits - 15, Routine Monitoring Visits - 90-100, Site Close out visits - 15 and Co-monitoring visits - 15
• Organize delivery of investigations product, laboratory packs, CRFs and other study specific materials to and from the clinical sites.
• To be a first line of communication to Vendors. Participate in the vendor / site audits as required.

Confidential

Clinical Research Associate

Responsibilities:

• CRA for Cardiovascular, Heart Failure, Diabetes Mellitus, Oncology - Prostate Cancer and Non Small Cell Lung Cancer
• Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulations and ICH guidelines.
• Regularly provide the clinical status information to team members and project management.
• Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results.
• Organize delivery of investigations product, laboratory packs, CRFs and other study specific materials to and from the clinical sites.

Clinical Research Associate

Confidential

Responsibilities:

• Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulations and ICH guidelines.
• To be a first line of communication to Vendors. Participate in the vendor / site audits as required.
• To leading and partake in regular team meeting / teleconferences.
• Assist, as appropriate, with reporting site performance regarding timelines and deliverables the clinical project team meetings and assist with feedback information on study organization and conduct for analysis of overall study performance.