With offices among the world's most populated cities, Pharm-Olam International provides cost effective coverage for full service or strategic outsourcing across all therapeutic areas and phases of research. Since 1994 we have used our local knowledge of an investigator's past performance, competing studies, and regulatory environment to offer sponsors an accurate and informed plan to complete trials on time.
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Acts as the focus for the 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 the day-to-day conduct of international clinical studies.
Assists CRAs, Lead CRAs (LCRA), Clinical Team Leaders (CTL) and Project Managers (PM) with the day-to-day administrations 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 maintenance of tracking information. Assists PM / CTL / LCRA / CRAs with collection and filing of critical documents and documentation required for submission to Regulatory Authorities and Ethical Committees. 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. Prepares Trial Master File according to Pharm-Olam SOPs. Reviews study related Trial Master File documentation to ensure compliance with SOPs and ICH-GCP on an ongoing basis, and before audit, inspection, or return of files to a Sponsor. Follows up study team or Sponsor requests for clarifications. Assists Project Manager with generation of study specific forms for Investigator Site Files. Attends Investigator and CRA meetings. Records questions and answers, and coordinates with the hotel staff to ensure smooth running of the meeting. Attends clinical teleconferences, and prepares and distributes minutes for Sponsor and Project Teams within agreed timelines. Prepares Investigator Site Files, Investigator Manuals and Training Manuals. Manages returning/archiving study files. Generates and reviews management reports from internal tracking systems at requested intervals. 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.
Education Requirements and Qualifications:
Experience of at least 1 year within a similar role or as a clinical research coordinator Sound knowledge of medical terminology and clinical monitoring process Ability to work independently and to effectively prioritize tasks Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and vendors Fluent English, both written and verbal
**Please note that you must be eligible to live and work in Germany in order to apply for this position**
CTA, CTA I, CTA II, CTA III, Senior CTA, Clinical Trial Associate, Clinical Research Coordinator, Permanent CTA, Contract CTA, Freelance CTA, CRO, Clinical Research Organisation, Office Based