Octalsoft,Oracle,EDC,Accelent,IWRS,CTMS,Etmf
Ms. Reshma Helode
Clinical Research Associate
Mumbai
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
8
8
years of professional experience
5
5
Certification
Work History
Clinical Research Associate
Karkinos Healthcare
10.2023 - Current
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Provide inputs in protocols and study documents, monitoring strategies and planning of the trial activities
- Support and assistance with pre-study activities including site feasibility, site selection etc. May be required support with IEC submissions to selected sites.
- Coordinate start-up activities and ensure timely IRB IEC submissions after the initial and subsequent approval, annual status reports, etc.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Manage clinical trials and clinical research studies by on site monitoring at every stage of the project with an eye for detail.
- Prepare the study files (TMF, SMF and ISF) and review and update them on an ongoing basis as per study requirements
- Involved in setting up the trial sites, which includes ensuring each centre has the trial materials, including the investigational medicinal product.
- Assist in developing training documentation and proactive identification of additional documentation needs.
- Handle various Audit Assessments, review requests and provide audit responses with required information on time
Clinical Research Associate
Macleods Pharmaceuticals Pvt Ltd
04.2022 - 07.2023
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Prepare the study files (TMF, SMF and ISF) and review and update them on an ongoing basis as per study requirements
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
- Provide inputs in protocols and study documents, monitoring strategies and planning of the trial activities
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
- Streamlined clinical trial processes for increased efficiency, utilizing strong organizational skills.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Implemented new technologies in the management of clinical trials, streamlining data collection and reporting processes.
- Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Conducted meetings with sponsor representatives to discuss clinical study developments.
- Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
- Created and maintained database and records filing system to document data on specimen collection, processing and storage.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Assisted in the preparation of regulatory submissions, supporting successful approval for clinical trials.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Established drug trial methodologies and procedures to support business and clinical trial endeavors.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Improved patient enrollment by developing and implementing effective recruitment strategies.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Maintained awareness of industry trends by attending conferences and participating in relevant professional development opportunities.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Assist with different stakeholders and vendor
Clinical Trial Associate
Macleods Pharmaceuticals Pvt Ltd Company
02.2020 - 03.2022
- Collaborated with data management teams to ensure accurate and timely entry of clinical trial data into the appropriate electronic systems.
- Prepare the study files (TMF, SMF and ISF) and review and update them on an ongoing basis as per study requirements
- Assist in developing training documentation and proactive identification of additional documentation needs.
- Support All enterprise metrics and reporting deliverables including problem management task to manage continuous improvement of application stability.
- Increased study efficiency through meticulous tracking of key performance indicators and prompt resolution of any issues identified.
- Simplified data collection processes by implementing user-friendly electronic data capture systems for improved accuracy and efficiency.
- Enhanced patient recruitment by streamlining screening procedures and maintaining accurate records.
- Managed study-related supplies inventory, ensuring adequate stock levels for smooth trial progression.
- Collaborated with investigators to address any concerns or issues that arose during the course of the clinical trial.
- Conducted regular audits of study files to ensure completeness, accuracy, and compliance with regulations.
- Ensured timely submission of safety reports, supporting overall patient safety throughout the trial process.
- Improved data quality by conducting thorough source document verification and resolving discrepancies in a timely manner.
- Assisted in budget preparation by analyzing resource requirements while maintaining costefficiency.
- Acted as a liaison between clinical sites and sponsors for effective communication regarding protocol amendments, enrollment updates, or other pertinent information related to trials.
- Facilitated efficient site initiation visits by preparing necessary documents and providing training on trial protocols.
- Assisted in the development of study-specific materials, including informed consent forms and case report forms, to ensure proper documentation and adherence to guidelines.
- Provided guidance regarding trial requirements and procedures to study staff, fostering a cohesive team environment.
- Provided administrative support such as scheduling meetings, taking minutes, and organizing travel arrangements as needed for project success.
- Contributed to successful trial completion by tracking patient progress and maintaining regular communication with study participants.
- Supported clinical trial execution by coordinating with cross-functional teams and ensuring regulatory compliance.
- Maintained up-to-date knowledge of industry best practices by attending relevant conferences, workshops, and webinars.
- Participated in the selection of appropriate clinical sites by evaluating potential locations and assessing capacity for successful trial outcomes.
- Prepared high-quality final reports upon completion of clinical trials documenting results achieved through careful monitoring of data trends.
- Organized investigator meetings to provide updates on trial progress and discuss potential improvements or adjustments to study plans.
- Taught patients about medications, procedures, and care plan instructions.
- Collected and documented patient medical information such as blood pressure and weight.
- Answered telephone calls to offer office information, answer questions, and direct calls to staff.
- Obtained and documented patient medical history, vital signs and current complaints at intake.
- Explained procedures to patients to reduce anxieties and increase patient cooperation.
- Helped improve patient outcomes by educating and advising on relevant treatments and care.
- Prepared lab specimens for diagnostic evaluation.
- Updated inventory, expiration and vaccine logs to maintain current tracking documentation.
- Managed investigational product inventory levels, ensuring adequate supply for all enrolled patients at each study location.
- Reduced study timelines by effectively coordinating efforts between cross-functional teams and external vendors.
- Assisted in the preparation of high-quality regulatory submissions, including informed consent forms, ethics committee applications, and safety reports.
- Streamlined clinical trial processes by implementing efficient data management systems and documentation practices.
- Developed strong relationships with site personnel, fostering a collaborative environment conducive to successful trial execution.
- Facilitated improved site performance with ongoing training sessions and timely feedback to clinical staff members.
- Provided critical support during audits or inspections by promptly addressing any concerns raised by regulators or sponsors regarding trial conduct or documentation practices.
- Handle Various Audit Assessments,review requests and provide audit responses with required information on time
- Oriented and trained new staff on proper procedures and policies.
- Conducted monthly and quarterly inventory of supplies using facility cost reporting records.
Customer Delight Officer(Pharmacy Officer)
Axelia Pharma Solutions Pvt Ltd
08.2019 - 12.2019
- Attended personnel meetings and training sessions to improve skills and learn new policies and procedures.
- Established effective relationships with key stakeholders both internally and externally for increased collaboration opportunities.
- Mentored junior staff members, helping them develop their skills and advance in their careers.
- Prepared and submitted detailed reports regarding assignments and ongoing investigations.
- Collaborated with physicians to best support patents
- Identified and reported any potential illegal or dangerous activity.
- Worked on as-needed basis, covering for absent pharmacist and assisting on heavy traffic workdays
Clinical Research Coordinator
Indira Gandhi Government Hospital
03.2019 - 08.2019
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Gathered, processed, and shipped lab specimens.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed informed consent processes and maintained records.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Managed study budgets and resources to maximize return on investment while maintaining quality standards.
- Streamlined data collection processes for increased efficiency and accuracy in study results.
Sr Hospital Pharmacist
Avanti Institute of Cardiology
08.2016 - 02.2019
- Drove improvements in medication dispensing accuracy, meticulously organizing and overseeing pharmacy's dispensing processes.
- Conducted thorough medication therapy management to identify and resolve medication-related problems, improving patient outcomes.
- Improved patient adherence to treatment plans by providing detailed consultations and tailored medication counseling.
- Assisted in the procurement process for medications, ensuring cost-effective purchasing decisions were made while maintaining high standards of quality assurance.
- Fostered culture of safety and vigilance within pharmacy, leading by example in adhering to regulatory standards and practices.
- Cultivated supportive and educational environment for pharmacy interns, guiding them through practical, hands-on training experiences.
- Achieved significant cost savings for pharmacy by negotiating better rates with suppliers, without compromising on medication quality.
- Provided ongoing mentorship and guidance to pharmacy staff members, fostering a collaborative work environment that prioritized patient care.
- Enhanced patient safety with meticulous review and verification of prescriptions for accuracy and appropriateness.
- Optimized patient safety by identifying and substituting medications with high-risk side effects with safer alternatives.
- Participated in medication utilization evaluations to identify areas for potential improvement in prescribing practices among clinicians.
- Assisted with the development of clinical practice guidelines and protocols to ensure evidence-based medication use across the institution.
- Collaborated with interdisciplinary healthcare teams to optimize patient care plans, resulting in improved therapeutic outcomes.
- Maintained strict compliance with relevant laws, regulations, policies, and procedures related to hospital pharmacy practice.
- Contributed to formulary management decisions, evaluating new drugs for safety, efficacy, and cost-effectiveness before inclusion into hospital formulary system.
- Improved patient satisfaction and trust by consistently delivering compassionate and knowledgeable service.
- Spearheaded vaccine administration program that expanded community access to vital immunizations.
- Implemented various medication therapy management services, such as drug therapy monitoring, pharmacokinetic dosing, and therapeutic drug monitoring.
- Assisted other pharmacy staff with drug inventory, purchasing and receiving.
- Dispensed and verified patient prescription orders, conducting necessary utilization reviews.
- Monitored ordering of pharmacy medication stock to maintain streamlined inventory and low overhead.
- Educated patients on proper medication use.
- Provided consultations and answered inquiries from patients, healthcare professionals and physicians regarding drugs, potential side effects, and specified use.
- Managed drug and supply inventories.
- Closely monitored department performance metrics.
- Counseled patients regarding proper intake of medications.
- Hand counted controlled medications, measured liquids and reconstituted antibiotics.
- Displayed patient-oriented and comprehensive clinical pharmacy services and pharmaceutical care.
- Completed accurate cycle counts, inventory management and will-calls for customers.
- Monitored medication dispensing machines within hospital pharmacy to make supplies readily available to clinical staff.
- Worked as preceptor to provide practice-based instruction to students at pharmacy practice sites.
- Streamlined pharmacy operations by implementing efficient inventory management practices, ensuring availability of essential medications.
- Dispensed and procured medicinal products and supplies used in hospital.
- Served as a preceptor for pharmacy students and residents, helping them develop vital clinical skills and knowledge.
- Enhanced patient education and understanding of complex medication regimens with clear, concise, and empathetic communication.
- Elevated standard of pharmaceutical care by staying abreast of and implementing current best practices and guidelines.
- Played pivotal role in emergency response efforts by ensuring prompt and accurate distribution of medications during critical situations.
- Developed effective relationships with physicians, nurses, and other healthcare professionals to ensure optimal communication and collaboration in patient care.
- Enhanced efficiency and reduced waiting times for patients by streamlining prescription filling process.
Education
Business Analyst - Business Administration And Management
COEPD
Pune 04.2001 -
Post Graduation Diploma in Clinical Research - Clinical Research
Spruce Institute
Nagpur 04.2001 -
B. Pharmacy - Pharmacy
DBCOP
Nagpur 04.2001 -
Skills
Stakeholder and vendor Management skill
Sprint planning, risk analysis,capacity planning
Jira and Agile project management tool experience
Sprint review and reporting
Problem-solving abilities
Relationship Building
Project Management
Action planning
Completing regulatory documents
Analytical Skills
Good Communication Skills and able to work in global environment
Time management abilities
Decision-Making
Software
Tools- Jira, Agile,Microsoft Visio, Balasmiq
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Marathi
Advanced (C1)
Certification
Business Analyst
Timeline
Business Analyst
09-2024
Clinical Research Associate
Karkinos Healthcare
10.2023 - Current
Clinical Research Associate
Macleods Pharmaceuticals Pvt Ltd
04.2022 - 07.2023
Clinical Trial Associate
Macleods Pharmaceuticals Pvt Ltd Company
02.2020 - 03.2022
Customer Delight Officer(Pharmacy Officer)
Axelia Pharma Solutions Pvt Ltd
08.2019 - 12.2019
Clinical Research Coordinator
Indira Gandhi Government Hospital
03.2019 - 08.2019
Sr Hospital Pharmacist
Avanti Institute of Cardiology
08.2016 - 02.2019
Business Analyst - Business Administration And Management
COEPD
04.2001 -
Post Graduation Diploma in Clinical Research - Clinical Research
Spruce Institute
04.2001 -
B. Pharmacy - Pharmacy
DBCOP
04.2001 -