Your Name
Brisbane,QLD
Summary
Results-oriented and highly experienced clinical trial projects specialist with global healthcare expertise in coordinating and managing clinical trials. Proven track record of ensuring compliance with regulatory standards, optimizing trial processes and facilitating successful collaborations between research teams and stakeholders. Adept at driving efficiency and quality throughout the clinical trial lifecycle.
Overview
18
18
years of professional experience
Work History
Clinical Trials Coordinator
Merck Sharp & Dohme
Sydney, NSW
02.2022 - 12.2023
- Coordinate and manage execution of Phase 1-Phase 4 clinical trials, overseeing validation, site selection, initiation, monitoring and closeout activities
- Play pivotal role in site ready timelines from feasibility checks, collect and track all Essential documents to creation of contractual and confidentiality agreements
- Positive feedback from managers for collaboration with stakeholders and quick-thinking approach
- Develop, coordinate, and maintain all regulatory submissions for clinical projects according to good clinical practice (GCP) guidelines, across multiple clinical project sites
- Prepare, distribute and report to all study managers adverse events via SUSAR, DSUR and PV
- Develop, control update and close-out country and site budgets
- Support CRA's for reconciliation documents and create Trial site Binders before SR
- Implement process improvements, resulting in 15% reduction in trial initiation time and 20% decrease in monitoring visit deviations
- Streamlined communication channels, fostering strong relationships with investigators, sponsors, and clinical teams
- Collaborate within global teams, and provide regular training to junior staff, SME and buddy support
- Increased efficiency by streamlining coordination processes and implementing new organizational systems
- Managed project timelines for successful completion, ensuring milestones were met and deadlines were adhered to
- Optimized trial efficiency through meticulous data management and timely report submissions.
Trial Associate
Chris O'Brien Lifehouse
Sydney, NSW
01.2021 - 11.2022
- Assess and process vendor invoices by validating patient visits in INFORM
- Process patient travel reimbursements in compliance with budgets and contractual agreements
- Managed coordination of multiple clinical trials simultaneously, ensuring adherence to protocols, data collection, timelines and regulatory requirements
- Participated in initiation visits and investigator meetings, implementing trials by study timelines and budgets
- Developed and maintained strong relationships with principal investigators, sponsors and clinical site staff, resulting in 15% improvement in trial satisfaction
- Enhanced patient recruitment by developing targeted outreach strategies for diverse populations
- Verify and Process vendor Invoicing in Tech1 by validating patient visits in INFORM
- Identify and close study queries for study coordinators by closing gaps in reporting.
Team Leader/Office Administrator
Chris O'Brien Lifehouse
Sydney, NSW
01.2015 - 12.2020
- Led a team of patient navigators to bring excellence in patient satisfaction and improved outcomes
- Recognized and awarded for Superior communication skills and patient satisfaction
- Designed and implemented projects for disabled access in Radiation Oncology department
- Managed patient life cycle of 200 patients per day by liaising effectively with medical teams and stakeholders for scheduling, billing and managing referrals
- Collaborate with other business units to facilitate interdisciplinary communication and coordination of care
- Provided exemplary customer service by answering questions, proactively solving problems, and creating a welcoming environment.
Patient Safety and Quality Improvement Officer
Wyckoff Heights Hospital
Brooklyn, New York
11.2008 - 01.2012
- Created staff training and performance management programs on vital subjects of leadership, effective communication, and healthcare denials
- Improved overall department efficiency by streamlining processes, patient surveys and implementing new policies
- Collated and classified incident reports according to risk imposed for clinical units
- Reported, investigated, and analyzed incidents including near misses to ensure accountability and continuous quality improvement
- Boosted team morale through recognition programs, resulting in higher productivity levels
- Identified barriers, developed strategies, and made recommendations for improved services in Obstetrics and Gynecology Department
- Ensure environmental safety for both staff and patients in relation to Occupational Health and Safety systems by conducting weekly Environment of Care tours on clinical units and in non-patient care areas of hospital with EOC Committee
- Monitored and communicated potential exposure to liability through EOC tours and emerging trend analysis in daily incident reports and claims
- Mentored junior staff members, helping them develop their skills and advance in their careers
- Developed projects with Patient Relations Team to develop heightened hospital awareness of benefits and opportunities that flow from first-rate service.
Sales and Marketing Coordinator
American Life Insurance
08.2005 - 01.2007
- Increased agency sales by up to 30% through telemarketing at American Life Insurance Co
- Successfully achieved higher sales through telemarketing with agency recognition
- Exercised sound judgment and critical thinking to make strategic decisions in increasing performance and efficiency
- Enhanced brand visibility through creation of engaging promotional materials and digital content
- Strengthened customer relationships with consistent follow-up, resulting in repeat business and referrals
- Streamlined internal processes for improved efficiency, reducing administrative workload for sales teams.
Education
MBA - Health Care Management
Dowling College
April 2009
BBA - Business Administration
University of Mumbai
April 2001
Post Graduate Diploma - Insurance and Risk Management
Jaipuria Institute of Management
Skills
- Project Management
- Regulatory Compliance
- Process Improvement
- Stakeholder Engagement
- Contracts and Data Management
- Analytical and quick action
- High Sense of accountability
- Work effectively in a matrix multicultural environment
- Proficient in clinical trial applications
- Adhered Good clinical Practice and NHMRC Principles
Timeline
Clinical Trials Coordinator
Merck Sharp & Dohme
02.2022 - 12.2023
Trial Associate
Chris O'Brien Lifehouse
01.2021 - 11.2022
Team Leader/Office Administrator
Chris O'Brien Lifehouse
01.2015 - 12.2020
Patient Safety and Quality Improvement Officer
Wyckoff Heights Hospital
11.2008 - 01.2012
Sales and Marketing Coordinator
American Life Insurance
08.2005 - 01.2007
MBA - Health Care Management
Dowling College
BBA - Business Administration
University of Mumbai
Post Graduate Diploma - Insurance and Risk Management
Jaipuria Institute of Management