Senior Clinical Support Associate Flex

The Senior Clinical Support Associate Flex provides in-house administrative support to the clinical project teams according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Sponsor SOPs.

Responsibilities

• Take on Lead CTA responsibilities on regional studies providing additional top-level project support and coordinating the regional CTA team.
• Act as a mentor to junior CTAs and to any temporary staff who are employed on an ad hoc basis. Assist with training for the team and be prepared to offer written feedback on performance of junior CTAs as part of the Sponsor appraisal process.
• Set up, co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including preparation for internal/external audits, final reconciliation and archival, according to the requirements of ICH GCP and Sponsor (or Novotech) SOPs. Lead and coordinate the TMF QC and review process.
• Coordinate the initiation and set up and maintenance of the Clinical Trial Management System (CTMS). Leading the review of CTMS compliance report to ensure study data is kept up to date.
• With direction from PM/CRA, manage and support the essential document management process according to Good Documentation Practice, ICH GCP and Sponsor (or Novotech) SOPs. Compile Project, Country and Site Activation Forms(s). Be responsible for drafting Essential Documents e.g. Financial Disclosures, Contracts, Indemnity, FDA 1572 etc. as per Sponsor SOPs and coordinate circulation for review as required by project team.
• Perform day-to-day vendor management, liaison, and tracking, as delegated by the PM.
• Perform planning and tracking of Investigator site finances, invoicing and finance reconciliation, as delegated by PM. Drafting and implementation of project SVT.
• Track study progress, as delegated by the Project Manager (PM) and provide updates / reports on study progress to LCRA/PM as required.
• Co-ordinate printing & distribution of ethics submission documents as requested by study team.
• Source, co-ordinate, track and manage distribution of study materials, data and documents between clinical sites, Novotech and Sponsor. Materials including Investigational Product, study equipment, lab kits, Investigator Site Files etc. according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Sponsor, and maintain stock reports as requested by the PM.
• Assist with drafting agenda and attending project team meetings and to generate and distribute meeting minutes, as delegated by the PM. Providing written and verbal updates if required.
• Assist the PM with drafting of relevant study plans where appropriate.
• In collaboration with the PM, be responsible for tracking and reporting of study SUSARs/CIOMS to the relevant stakeholders, i.e. Regulatory Authorities, Investigators and Client according to the Safety Management Plan and Clinical Monitoring Plan, and local regulatory requirements.
• Provide in-house support to the study CRAs & PMs, contacting site staff/ Investigators on behalf of the CRA or PM to request information or resolve issues as required. Provide on-site administrative assistance to CRAs if required.
• Lead organisation of Investigator Meetings including venue and vendor selection as delegated by the Sponsor and/or PM.
• May take on a Systems Super User/Administrator role such as CTMS as required by the needs of the Clinical Operations department.
• Be aware of and adhere to company processes in areas relevant to a SCTA. Be quality minded in performance of duties. Adhere to Novotech and Sponsor’s policies and be mindful of the role of Novotech ambassador when carrying out SCTA role.
• Participate in activities of the Clinical Operations department, including presentation at clinical team meetings, attendance at company meetings and contributing to the development of clinical processes and SOPs.
• Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.
• Be responsible for good customer satisfaction of individual performance.

Qualifications

• At least 18 – 24 months experience in a Senior Clinical Support Associate Flex role or equivalent. Practical experience and/or qualifications in business administration or healthcare administration.
• Prior background in the pharmaceutical, CRO or healthcare industry is advantageous.

Skills and Competencies

• Strong customer focus, attention to detail, excellent communication and interpersonal skills and the ability to multi-task and function independently as required.
• Good computer literacy e.g., MS Word, Excel, PowerPoint, internet.
• Good in maintaining good working relationships with sponsors members.