Clinical Research Associate

4 days ago

Fatih, Istanbul, Turkey PDC CRO Full time

Essential Functions and Other Job Information

  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  • Site selection and qualification evaluation under supervision of senior personnel.
  • Assists during a study set-up regarding a submission and approval process and preparation of the documentation as per all applicable local requirements.
  • Collects all ECs requirements per allocated studies.
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance. Strictly follows everything stipulated under ICH-GCP, point 5.18.
  • Review and reporting of all non-compliances/ protocol deviation, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  • Reporting of trial progress to the CPM by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc).
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Adheres to the rules and regulations of ICH-GCP and other regulatory and ethical guidelines and data protection regulations.
  • Timely coverage of all assigned trainings.
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalisation of contracted tasks.
  • First line of communication for any study related issues arisen by sites for studies lead by them.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Responsible for issues escalation following the proper escalation pathway.

Qualifications

Education and Experience

  • University degree with life science background or equivalent and relevant formal academic/ vocational qualification.
  • At least 1 year of experience in the field of clinical research.
  • In case of internal promotion: successfully pass internal CRA assessment.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities

  • Good knowledge and practical aspects of implementation of ICH-GCP guidelines.
  • Good working knowledge of Business English.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Basic medical terminology knowledge.
  • A valid driving license and willingness to travel within the country and abroad (upon flexible working schedule).
  • Good time management and multitasking skills to coordinate several studies simultaneously.
  • Solid interpersonal skills.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Appropriate MS Office Skills.
  • May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
  • Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
  • Ability to perform under stress.

Working Conditions and Environment

  • Work is performed in an office/ home-office environment with exposure to electrical office equipment.
  • Often travels/ drives to site locations. Frequent travel both domestic and international.

About PDC

Pharmaceutical Development Company is a leading clinical research organization, providing the full range of Phase I to IV clinical development services. Our clients include pharmaceutical, biotechnology, medical device industries, other CROs, and academic organisations. Our team is experienced in managing clinical projects from beginning to completion, PDC has been recognized among the leaders as Clinical Research Organization in the region.

We cover Middle East and Africa Region

Website: http://www.pdc-cro.com

Seniority level
  • Entry level
Employment type
  • Full-time
Job function
  • Research, Analyst, and Information Technology
  • Industries: Pharmaceutical Manufacturing
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