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Senior Clinical Trials Assistant

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

RESPONSIBILITIES Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness. Collaborate with CTL on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. Assist in training and orienting new staff. May act as a mentor for less experienced CTAs. May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval. May perform assigned administrative tasks to support team members with clinical trial execution. All responsibilities are essential job functions unless noted as nonessential (N).REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines Knowledge of applicable protocol requirements as provided in company training Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint Strong written and verbal communication skills including good command of English language Effective time management and organizational skills Attention to detail and accuracy in work Ability to establish and maintain effective working relationships with coworkers, managers and clientsQualifications MINIMUM REQUIRED EDUCATION AND EXPERIENCE School diploma/certificate or educational equivalent; or equivalent combination of education, training and experiencePHYSICAL REQUIREMENTS Extensive use of telephone and face-to-face interactions, which require accurate perception of speech Extensive keyboarding involving repetitive motions with fingers Regular sitting for extended periods of time Packaging and lifting supplies for storage and shipping Occasional travel
Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 2-5


Chemist | Clinical Research | Data Management/ Statistics | Quality Assurance/ Control
Applying for this job will take you to an external site


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