Pharm-Olam International Clinical Trial Associate in Munich, Germany

About Pharm-Olam International:

Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach, then look no further, because Pharm-Olam International offers all of this and more. 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:

Acts as the primary contact for project team administration and provides the Project Manager and all other project team members with advice, assistance and support, as required, thus ensuring that the clinical trial is conducted in accordance with international regulatory and ethical guidelines for Good Clinical Practice and Standard Operating Procedures. Assists the study team with day-to-day conduct of international clinical studies with guidance as required.

  • Assists CRAs, Lead CRAs (LCRA), Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administration of clinical studies.

  • Tracks critical documents and informs PM / CTL and/or LCRA of outstanding documents.

  • Accurately updates and maintains clinical systems within project timelines.

  • Prepares, distributes, files, and archives clinical documentation Reviews study files periodically for accuracy and completeness.

  • Prepares and distributes clinical trial supplies and maintains tracking information.

  • Assists PM / CTL / LCRA / CRAs with collection and filing of critical documents and documentation required for submission to Regulatory Authorities and Ethics Committees.

  • Attends local Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting.

  • May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.

  • Performs administrative tasks to support team members with clinical trial execution, as required.

  • Attends clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines.

  • Follows up study team requests for clarifications, supplementary information.

  • Assists PM with generation of study specific forms for Investigator Site Files.

  • Prepares Trial Master File according to POI SOPs, with guidance as required.

  • Prepares Investigator Site Files, Investigator Manuals and Training Manuals, with guidance as required.

  • Manages returning/archiving study files, with guidance as required.

  • Generates and reviews management reports from internal tracking systems at requested intervals.

  • As needed, communicates with sites regarding trial start-up, conduct, and close-out activities at requested intervals, if needed.

  • May participate in feasibility and/or site identification activities.

Working Relationship:

  • Reports to Clinical Trial Associate Manager, COM or designee

  • Collaborates with project teams and all POI staff

  • Communicates with Sponsor and sub-contractors, if requested by Project Manager

  • Experience of at least 1 year within a similar role or as a clinical research coordinator

  • All requirements of Clinical Trial Associate I

  • Fluency in English (spoken and written)

  • Customer service orientation

  • Sound knowledge of medical terminology and clinical monitoring process

  • Strong verbal and written communication skills

  • Computer literacy, proficiency in Microsoft Office

  • Excellent interpersonal and organizational skills

  • Ability to work independently and to effectively prioritize tasks

  • Ability to manage multiple projects

  • Attention to detail

  • Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and vendors

For Consideration: Please forward resume and salary requirements for confidential consideration via email at desiree.futrell@pharm-olam.com or fax to (832) 202-0564. Due to the number of inquiries, we are unable to respond to each inquiry. Candidates of interest, matching the above qualifications will be contacted for further consideration.

PRINCIPALS ONLY, NO PHONE CALLS PLEASE.

ID: 2016-1217