Barrington James is currently partnered with a mid-sized CRO with a massive global reach. They are a company who Endeavour to always deliver cost effective, quick to market clinical services in the emerging marketplace. They have a unique work environment with a global team culture due to their large global footprint. They are committed to not only maintaining their standard, but to continue to strengthen their presence further.
They are looking for a CTA to act as the focus for the project team administration and provide the project manager and all the other 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. Reports to the Clinical Trials Associate Manager, COM or Desingee.
(Include but not limited to)
- 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.
- 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.
- Provides training and mentoring, as required, on POI procedures and clinical trial administration. Resolves logistical and practical issues.
- Prepares Trial Master File according to POI 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, supplementary information.
- Assists PM 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.
- 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.
- Experience of at least 2 years within a similar role or as a clinical research coordinator
- All requirements of Clinical Trial Associate II
- 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
- Good presentation skills
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and vendors.