Clinical Research Associate II
CLINIPACE
Poland
20 d. temu

Job Overview :

The Clinical Research Associate II monitors investigational sites to ensure subject safety and provides high-quality data review and reporting in compliance with the CPWW and / or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations.

Builds, manages and supports site relationships while serving as a liaison between the Sponsor and assigned sites.

Job Duties and Responsibilities :

  • Provides support to Project Team and Clinical Operations Team.
  • Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
  • Demonstrates strong written and verbal communication skills.
  • Serves as primary contact for assigned research sites.
  • Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
  • Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
  • Ensures assigned sites are conducting studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verifies that the rights and well-being of trial subjects are protected.
  • Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
  • Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
  • May support translations of essential documents
  • May support submission of trials to IRB / IEC and regulatory authorities.
  • Verifies that written informed consent was obtained before each subject’s participation in the trial.
  • Verifies that the investigator is enrolling only eligible subjects.
  • Performs source data verification against Case Report Form / Electronic Data Capture entries in compliance with the Monitoring Plan.
  • Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff.

  • Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site.
  • Performs Investigational Product accountability, including product storage, inventory, return / destruction, and dispensing / receipt records.
  • Verifies and supports the recording and reporting of adverse events / serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan.
  • Ensures that sites have sufficient project specific supplies.
  • Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals.
  • Communicates deviations from the protocol, SOPs, and / or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
  • Delivers quality written trip reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
  • Attends and participates in team teleconferences and training.
  • Participates in relevant trial meetings, e.g. Kick off, Investigator, and Monitor meetings.
  • Participates in site audits, as requested.
  • May conduct site and study feasibility assessments.
  • May be involved in the development of monitoring guideline and tools.
  • Provides input into study documentation and monitoring worksheets.
  • Uphold the confidentiality agreements with all clients and colleagues outside Clinipace Worldwide (CPWW).
  • Pays attention to signals of fraud, misconduct and escalates per CPWW SOP.
  • Work according to the CPWW Quality Management System and actively participate in giving feedback and suggesting improvements to current processes.
  • Work according to the project-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the CPWW time allocation system.
  • Demonstrates flexibility and adaptability.
  • Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
  • Other duties as assigned by Clinical Operations Manager / Project Manager and per project-specific requirements.
  • May participate in delivering Clinical Monitoring portion of a bid defence presentation.
  • Supervisory Responsibilities : None

    Job Requirements : Education

    Education

  • 4 year college graduate, preferably with a healthcare or life science degree.
  • In lieu of a degree, candidates with 2 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Experience

  • Minimum of 1 year of experience in on-site monitoring clinical studies.
  • Skills / Competencies

  • Strong written and verbal communication skills
  • Strong interpersonal skills
  • Strong monitoring skills to independently conduct all types of site monitoring visits
  • Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding)Proficient computer skills, including Microsoft Office
  • Comprehensive knowledge of GCP / ICH guidelines
  • Proficiency in medical terminology
  • Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
  • Attention to detail
  • Problem-solving skills
  • Ability to work in a matrix environment
  • Strong time management and organizational skills
  • Capabilities

  • Ability to drive an automobile and have a valid driver’s license, if applicable.
  • Valid passport required in the case of international business travel.
  • Ability to travel up to 80%.
  • The company will not accept unsolicited resumes from third-party vendors.

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