Shalinee Singh

• Kept patient care protocols and clinical trial operations in compliance.
• Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
• Took vital signs and collected medical histories as part of study protocols.
• Conducted screening interviews to determine eligibility of possible subjects.
• Educated participants on studies and anticipated outcomes.
• Promoted high customer satisfaction by resolving problems with knowledgeable and friendly service.
• Understood and followed oral and written directions.
• Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
• Identified needs of customers promptly and efficiently.
• Prioritized and organized tasks to efficiently accomplish service goals.
• Demonstrated leadership by making improvements to work processes and helping to train others.
• Planned and completed group projects, working smoothly with others.
• Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Collected data and followed research protocols, operations manuals, and case report form requirements.
• Gathered, processed, and shipped lab specimens.
• Reviewed referral information and kept track of intakes from various referral sources.
• Complied with research protocols by providing ongoing quality control audits.
• Collected, evaluated, and modeled collected data.
• Facilitated focus group sessions with project patients.
• Monitored unit budget to meet financial objectives for spend rate and funding.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Developed and maintained accurate and up-to-date case report forms and source documents.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
• Managed patient recruitment, informed consent process and data entry to support trial objectives.
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
• Maintained accurate and up-to-date case report forms and source documents for traceability.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
• Monitored patient safety throughout clinical trials and reported any adverse events.
• Followed informed consent processes and maintained records.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Instructed and advised patients regarding preventive health care measures to promote early detection, diagnosis and management of medical conditions.
• Participated in patient education sessions among targeted populations with prevalent health risk factors.
• Monitored post-operative recovery and educated patients on at-home recovery.
• Identified serious conditions and emergency situations and immediately referred to hospital for prompt care.

Project Description:

• Ophthalmic Clinical Research Phase III
• Diabetic Macular Edema III (Global Trial)
• Choroidal Neovascular Membranes III(Global Trial)
• Glaucoma Study EMEA

Client 1: Syneos Health

• Project Description - Diabetic Macular Edema III (Global Trial), Choroidal Neovascular Membranes (CNVM), Wet age-related macular degeneration (WAMD)
• Phase Indication- III

Client 2: IQVIA

• Project Description - Glaucoma Global Study EMEA (Global Study)
• Phase Indication - Phase III

Client 3: Lupin Limited

• Project Description - Choroidal Neovascular Membranes (CNVM)
• Phase Indication - Phase III

Client 4: PPD

• Project Description - Choroidal Neovascular Membranes (CNVM)
• Phase Indication- III

• Used variety of learning modalities and support materials to facilitate learning process and accentuate presentations.
• Evaluated and revised lesson plans and course content to achieve student-centered learning.
• Developed and implemented innovative teaching strategies to engage students in lectures and coursework.
• Arranged syllabus, developed schedule, and determined reading list for varied courses simultaneously, giving students appropriate time to complete assignments and absorb information.
• Created excitement and enthusiasm in classroom by delivering engaging subject matter.
• Created positive and safe learning environment for students by setting and enforcing classroom code of conduct.
• Applied innovative teaching methods to encourage student learning objectives.
• Guided students in researching, structuring and presenting debate case.
• Designed and implemented various educational activities and programs to meet student needs.
• Contributed to planning appropriate and engaging lessons for both classroom and distance learning applications.
• Evaluated and supervised student activities and performance levels to provide reports on academic progress.
• Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback.
• Taught diverse student population by employing various learning styles and abilities.
• Conducted engaging in-class discussions to facilitate learning and encourage participation.
• Impartially evaluated papers, projects and homework assignments of students, delegating grading to teaching assistants when appropriate.
• Met with students to dispense study and career advice and provide guidance and potential opportunities within chosen field.
• Participated in various campus memberships at each assigned school to promote academics and faculty development.
• Created materials and exercises to illustrate application of course concepts.