Senior Clinical Research Associate

CLINIPACE (Italy | Milan, Italia) Pubblicato 4 giorni fa

Job Duties and Responsibilities:

  • Provides support to Project Team and Clinical Operations Team.
  • Maintains strong 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 the scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
  • Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines.
  • Verifies 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 high quality written trip reports, confirmation and follow-up letters within timelines of SOPs and monitoring plans.
  • Participates in site audits, as requested.
  • May conduct site and study feasibility assessments.
  • Provides input into study documentation and monitoring worksheets.
  • Uphold the confidentiality agreements with all clients and colleagues outside Clinipace  (CP).
  • Pays attention to signals of fraud, misconduct and escalates per CP SOP.
  • Work according to the CP 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 CP time allocation system.
  • May perform Trip Report review, management, resolution and escalation.
  • May conduct project co-monitoring visits and team training.
  • May conduct Team calls and Sponsor calls (as needed).
  • May provide project-specific performance feedback.
  • May serve as site contact for protocol clarifications and subject enrollment.
  • May manage Protocol Deviation documentation, tracking, and escalation.
  • May relate project status and issues to Project Manager and/or CRAs.
  • May serve as Sponsor contact for monitoring/site issues.
  • May assist the Project Manager with coordination and management of the project budget, grant administration and project invoicing.
  • Attends and participates in team teleconferences/meetings providing mentoring and training.
  • Participates in relevant trial meetings, e.g. Kick-off, Investigator, and Monitor meetings, and provides support, as requested.
  • Demonstrates flexibility and adaptability.
  • Assists project team in development of monitoring guideline and tools.
  • Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently.
  • Provides support to Project Team and assume additional roles on the team as necessary.
  • Provides mentorship, training and direction to Clinical Research Associates when needed.
  • 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 defense presentation.

Supervisory Responsibilities:   None

Job Requirements:

  • Education
    • 4 year college graduate, preferably with a healthcare or life science degree.
    • In lieu of a degree, candidates with 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.
  • Experience
    • Minimum of 3 years of experience in on-site monitoring of clinical studies
    • Monitoring experiences in several different indications and study types
    • Experience in all areas of monitoring (on-site, remote, etc.)
    • Oncology experience is needed
  • Skills/Competencies
    • Strong written and verbal communication skills
    • Strong interpersonal skills
    • Expert 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)
    • Strong 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.
    • Exceptional attention to detail
    • Superior problem-solving skills
    • Assist in training/mentoring guidance and presentation skills.
    • Ability to work in a matrix environment
    • Exceptional 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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