Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Certification
Timeline
Generic

Valanciya Macwan

Vadodara,GJ

Summary

Strong research professional with years of clinical trial experience. Considerable experience as a Clinical Research Coordinator and Research Specialist dealing with complex issues, escalations, projects, patient recruitment, query resolution and study coordination. Knowledgeable Clinical research coordinator adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues. Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level clinical research coordinator position. Ready to help team achieve company goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Clinical Research Coordinator

WeCare (SMO)
Vadoadara , GJ
05.2023 - 10.2023
  • Assist with day-to-day activities according to protocol .
  • Assist with maintenance of laboratories (general lab and equipment maintenance, restocking, clean outs, etc.)
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Gathered, processed, and shipped lab specimens.
  • Followed informed consent processes and maintained records.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • 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.
  • Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
  • Improved recruitment rates by developing and implementing effective patient outreach strategies.
  • Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
  • Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
  • Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
  • Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
  • 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.
  • Streamlined data collection processes for increased efficiency and accuracy in study results.

Clinical Research Coordinator

PROCR Solutions
Vadodara, GJ
09.2018 - 11.2019
  • Handles administrative activities associated with conduct of clinical trials
  • Maintains data pertaining to research projects, creates, and completes source documents/case report forms, and performs data entry
  • Assists with patient/participant recruitment and creates standard works
  • Attends and schedules study meetings
  • Orders and maintains equipment and supplies
  • Reviews medical records and/or conducts screenings for recruitment of study participants, performs interviews and QOL questionnaires
  • Collects study specimen according to protocol which may include blood processing, and preparation for shipping
  • Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges
  • Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors
  • Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires
  • Assist with creating standard works and SOP’s
  • Serves as lead study coordinator for several clinical trials Phase 1 -3
  • Manages over 30+ study participants.
  • Assist with hiring new Clinical Coordinators/ Conducts interviews
  • Assist with training less experienced staff
  • Ensures that study data and systems are maintained and accurately documented
  • Primary contact for study monitors
  • Collected data and followed research protocols, operations manuals and case report form requirements

Education

Master of Science - Clinical Laboratory Technology

Sardar Patel University
Anand, GJ
05.2016

Bachelor of Science - Biology

Sardar Patel University
Anand, GJ
05.2014

Post Graduate Diploma in Clinical Research - Health Science And Training & Management

Cliniminds
Vadodara, GJ
08.2017

Skills

  • Informed consent process
  • Medication dispensing
  • Research SOPs understanding
  • Good Clinical Practices
  • Electronic Data Capture (EDC)
  • Patient Recruitment and Eligibility
  • Query resolution
  • Study Coordination
  • Data management
  • Microsoft Office

Websites

Accomplishments

  • Regine Harris,Corshe Claire,Elimelda Moige Ongeri. Hypoxia Induced Redistribution of OS-9 in Kidney Cells. The FASEB Journal 2015; 29:663-6.
  • Barry Lee Martin, Sabena Michelle Conley, Regine Simone Harris, Corshe Devon Claire, Jean-Marie Vianney Niyitegeka, Elimelda Moige Ongeri. Hypoxia Associated Proteolytic Processing of OS-9 by the Metalloproteinase Meprin β. Int J Nephrol. 2016: 2851803. PMCID: PMC4961814 PMID: 27478637



Certification


  • [CITI PROGRAM: Basic/Refresher Course Human Subjects Protection] Training - [Expires: October 2024]
  • [CITI PROGRAM: Good Clinical Practice (GCP)] Training - [Expires: October 2024]
  • [CITI PROGRAM: Health Privacy and Information Security] Training - [Expires October 2024]
  • [AHA Basic Life Support or CPR] Training - [No Expiration]

Timeline

Clinical Research Coordinator

WeCare (SMO)
05.2023 - 10.2023

Clinical Research Coordinator

PROCR Solutions
09.2018 - 11.2019

Master of Science - Clinical Laboratory Technology

Sardar Patel University

Bachelor of Science - Biology

Sardar Patel University

Post Graduate Diploma in Clinical Research - Health Science And Training & Management

Cliniminds

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Valanciya Macwan