Pharm-Olam International

  • Experienced Clinical Research Associate

    Job Locations PL-Warsaw
    ID
    2016-1212
    Category
    Clinical - CRA
  • Overview

    About Pharm-Olam International: 

    Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

    Summary: 

    Ensures that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).

    Responsibilities

    • Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and POI SOPs for monitoring requirements
    • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
    • Collects and reviews regulatory documents as required
    • Prepares site visit reports and telephone contact reports
    • May participate in the start-up process including reviewing protocols, reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings
    • Resolves site issues, including site recruitment challenges, and determines status for IP shipment
    • Works with Project Manager (PM), Clinical Team Leader and/or Lead CRA (CTL/LCRA), regulatory team members or sponsor to secure authorization of regulatory documents and site contracts
    • Informs team members of completion of regulatory and contractual documents for individual sites
    • Attends Investigator Meetings (IM) and study specific training meetings
    • May translate, coordinate translations or review completed translations of critical documents
    • Participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identify sites with the potential for participation. Follows the feasibility procedures for documentation of feasibilities performed
    • Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required
    • Assists the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings
    • Provides secondary in-house review of CRFs/eCRFs (if required)
    • Works both independently and in a team environment.

     

    Working Relationship: 

    • Reports directly to Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager
    • Collaborates with POI project team members
    • Collaborates with POI and local support personnel
    • Liaises with Investigators, Site Staff, and Regulatory Authorities and Ethics Committees
    • Liaises with Sponsor scientific and medical personnel
    • Liaises with Vendors and Sub-contractors such as Central Laboratory and Courier organizations
    • Liaises with Quality Assurance personnel.

    Qualifications

    • At least two years clinical monitoring experience or relevant clinical trial experience
    • Relevant life science degree / medical / nursing background or equivalent
    • Customer service orientation
    • Sound knowledge of medical terminology and clinical monitoring process
    • Attention to detail
    • In-depth therapeutic and protocol knowledge Ability to perform travel an average of 65%, depending on project needs
    • Excellent communication in English in both written and verbal skills
    • Computer literate and proficient in Microsoft Office
    • Excellent interpersonal and organizational skills
    • Ability to work independently and to effectively prioritize tasks, establish and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients
    • Ability to manage multiple projects
    • Ability to develop, organize and manage new skills and tasks.

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