Description

• QA responsibilities include:
  • Performing QA functions pertaining to (but not limited to) Change management, CAPA, Deviation,
  Internal Audits, External Audits, Risk management, Innovation and Continual improvement.
  • Understanding GXP requirements such as (but not limited to) GCP, GVP, GMP, GDocP etc. and
  implementing/ monitoring them for QA function, as applicable.
  • Facilitating the process of initiation of investigations and CAPAs, monitor progress and perform
  reviews/approvals.
  • Ensuring that CAPA procedures and requirements are followed and met. Uphold standards for
  quality and compliance in pharmacovigilance.
  • Escalating and involve stakeholders for resolution as needed, issues impacting the progress toward
  completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records.
  • Reviewing evidence and approve closure of CAPA plans and effectiveness monitoring plans.
  • Facilitating regular CAPA status and metric reports to ensure senior management awareness.
  • Participating in governance/oversight activities including trend assessment or other quality review.
• CRA responsibilities include:
  • The Clinical Research Associate III (CRA III) monitors clinical studies and assures high quality of the
  clinical data.
  • Keeps him/herself professionally abreast of all scientific, regulatory and operational aspects
  relevant to the clinical projects he/she will be assigned
  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by
  obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • May acts as Feasibility Associate (FEA) after appropriate and documented training
  • Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP
  compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy,
  legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol,
  SOP’s and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Attends and may present at Investigator Meetings (IM) and study specific training meetings.
  • May translate, coordinate translations or review completed translations of critical documents.
  • Conducts source data verification and in house review of clinical data and ensuring timely
  resolution of data queries to guarantee reliable clinical data
  • Manages the investigational products (storage, inventory, dispensing records, packaging and
  labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc) to
  ensure timely and correct supply to the site
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues
  (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up,
  guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g. archiving) guaranteeing
  smooth completion of the project
  • Is the main contact person for the site in order to ensure close follow up
  • Provides general support to the Clinical Research Division (CRDIV) on quality control of clinical
  data
  • Promptly addresses the Projects Coordinators (PCs)/ Project Managers (PMs)/ Senior Project
  Managers (SPMs) about any issues that can jeopardize the conduct of the clinical projects
  assigned
  • Reports to the Head of Clinical Monitoring Unit (CMU-H) or delegate on all activities performed
  during the study and sends all relevant documents according to the timelines and the
  requirements agreed for each single clinical trial
  • Develops training material and gives trainings to CRDIV in collaboration with the Training &
  Qualification Management Unit (TQMU)
  • May assist in contract negotiation with sites on study budget after appropriate and documented
  training
  • Assists the preparation of the study including CRF design/development, writes CRF instructions,
  organizes the study files and documents to ensure good start-up of the investigation sites
  • May support the submission process in the project (or region), including submission
  requirements, timelines, informed consent development, etc. after appropriate and
  documented training. Accordingly he/she can be required to provide updates on the applicable
  regulation for the application process in the country of work, whenever relevant
  • Guides and supervises Clinical Research Associates I (CRAs I)/ Clinical Research Associates II
  (CRAs II) in order to coach and train them on the job
  • Perform co-visits with Clinical Research Associates I (CRAs I)/ Clinical Research Associates II
  (CRAs II)

Requirements

• Qualification:  Should have Bachelor’s Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred. In some cases an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Years of Experience

• Should have Eight (8) years (at least) of experience as a CRA

Skills

• • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable
  regulatory requirements
  • Sound knowledge of medical terminology.
  • Ability to manage more than 1 study simultaneously.
  • Fluent in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness and ability to travel up to 50-80%, this may increase or decrease depending on the
  project needs.

• Interested candidates can share their updated CVs to saba.naaz@clinchoice.com