Summary
Overview
Work History
Education
Skills
Language Skills
Job Title
Accomplishments
Software
Certification
Interests
Volunteering
Timeline
AdministrativeAssistant
Ipek Sila Erdinc

Ipek Sila Erdinc

Clinical Research Associate II
Miami,FL

Summary

Accomplished Clinical Research Associate with 5 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards.

Overview

7
7
years of professional experience
30
30
Certification
3
3
Languages

Work History

Clinical Research Associate II

Parexel International
Miami, FL
03.2023 - Current
  • Clinical sites' main point of contact, accountable for quality and delivery of sites from Initiation to Close out of the trial
  • Oversees the conduct of the trial at designated sites ensuring the rights and well-being of human subjects are protected, quality and integrity of the reported data and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s)
  • Generated visit/contact reports, using judgment to identify site issues and problem solving to direct resolution
  • Collected, reviewed, and approved (if applicable) updated/amended site documentation, including regulatory documents as applicable
  • Reviewed site recruitment plan in collaboration with the site staff on an ongoing basis
  • Performed and reported on-site visits and remote contacts in accordance with the monitoring plan; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolved site issues, questions and concerns
  • Assessed & managed test article/study supply including supply, accountability and destruction/return status
  • Conducted on-site study-specific training (if applicable).
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
  • Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
  • Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Gathered and organized clinical trial documentation to meet rigorous standards for site approval.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Established drug trial methodologies and procedures to support business and clinical trial endeavors.
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Submitted routine reports and follow-up letters to facilitate internal and external communication.
  • Created and maintained database and records filing system to document data on specimen collection, processing and storage.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
  • Supported development and delivery of department training to maximize success of clinical research.
  • Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
  • Conducted meetings with sponsor representatives to discuss clinical study developments.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Observed clinical studies and assessed health outcomes in groups of participants to support research plan.

Clinical Research Associate II

Parexel International
Istanbul
09.2021 - 03.2023
  • Assured compliance with local regulations, CFR/ICH and GCP guidelines and Company and Sponsor SOPS
  • Maintained timely and effective communication among team members and site staff
  • Performed SDV according to contractual requirements
  • Assured timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan
  • Assured completion of Data Clarification Forms
  • Prepared for and attends Investigator meetings; may present materials, as requested
  • Attended clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring and/or training plans
  • Reviewed data queries and listings and worked with study sites to resolve data discrepancies
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.

Clinical Research Associate I

Parexel International
Istanbul
11.2020 - 09.2021
  • Addressed and resolved issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training
  • Determined and implemented appropriate follow-up action with the input of other/relevant parties and / or guidance provided, if applicable
  • Reviewed site recruitment plan in collaboration with the site staff on an ongoing basis
  • Issues, questions and concerns
  • Assessed & managed test article/study supply including supply, accountability, and destruction/return status
  • Conducted on-site study-specific training (if applicable)
  • Performed site facilities assessments

Clinical Research Associate

VSY Biotechnology
Istanbul
12.2019 - 11.2020
  • Wrote and developed trial protocols (outlining purpose and methodology)
  • Designed data collection forms, known as case report forms (CRFs)
  • Collected completed CRFs from hospitals and general practices
  • Wrote visit reports and file and collate trial documentation and reports
  • Closed down trial sites on completion of the trial and prepared final reports and occasionally manuscripts for publication
  • Performed clinical study site management/monitoring activities in compliance with GCP.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Created and maintained database and records filing system to document data on specimen collection, processing and storage.
  • Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Observed clinical studies and assessed health outcomes in groups of participants to support research plan.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Liaised with clinical project leader to effectively resolve study-related issues.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.

Clinical Study Coordinator

Altis CRO
Istanbul
03.2018 - 12.2019
  • Scheduled patient visits
  • Followed up on protocol compliance issues
  • Coordinated patient files in accordance with protocol & ICH-GCP
  • Reported AE/SAEs
  • Collected samples and organized shipments
  • Followed up on MOH and Ethical Committee submissions.
  • Followed informed consent processes and maintained records.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • 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.
  • Gathered, processed, and shipped lab specimens.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • 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.
  • Facilitated focus group sessions with project patients.

Clinical Study Coordinator

Monitor CRO
Istanbul
04.2017 - 03.2018
  • Scheduled patient visits
  • Followed up on protocol compliance issues
  • Coordinated patient files in accordance with protocol & ICH-GCP
  • Reported AE/SAEs
  • Collected samples and organized shipments
  • Followed up on MOH and Ethical Committee submissions.

Education

MA in Management of Pharmaceutical Industry -

Acibadem University

BSc in Biology - undefined

Kocaeli University

Skills

Trial methodologies

undefined

Language Skills

  • Turkish - Native
  • English - Fluent
  • Spanish - Beginner

Job Title

Clinical Research Associate II

Accomplishments

  • Wrote 2 protocol for 2 new study with medical team
  • Had 2 Audit with minor findings
  • Worked with Turkey, UK and USA sites.
  • Supervised team of 10 staff members.
  • Supported sites and reached target subject numbers.

Software

Microsoft Office

C

Certification

GCP Training

Interests

High Heels Dance

Yoga

Travelling

Modern Dance

Tango

Creative Drama

Volunteering

Natura and Animal Friends Club - Volunteer (2011/2016)

Haytap Animal Rights Federation - Rescue, First Aid and Clinic Volunteer (2016/2023)

Child Welfare Institution - Volunteer (2016/2020)


Timeline

Clinical Research Associate II

Parexel International
03.2023 - Current

GCP Training

02-2023

Clinical Research Associate II

Parexel International
09.2021 - 03.2023

Clinical Research Associate I

Parexel International
11.2020 - 09.2021

Clinical Research Associate

VSY Biotechnology
12.2019 - 11.2020

Clinical Study Coordinator

Altis CRO
03.2018 - 12.2019

Clinical Study Coordinator

Monitor CRO
04.2017 - 03.2018

MA in Management of Pharmaceutical Industry -

Acibadem University

BSc in Biology - undefined

Kocaeli University

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Ipek Sila ErdincClinical Research Associate II