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| Job Location | Kolkata |
| Education | Not Mentioned |
| Salary | Rs 3.0 - 7 Lakh/Yr |
| Industry | Medical / Healthcare |
| Functional Area | Medical Transcription |
| EmploymentType | Full-time |
Experience 0 to 1 year & Freshers can ApplySkills required- CRA knowledge, CRC knowledge, Patient Data knowledge, ICH - GCP, ICF, Adverse Events/ SAEs, site monitoring, remote site monitoring knowledge. (eTMF - experience - not mandatory but preferred).PURPOSE:Provide project related assistance for assigned complex project(s), sites and project teams. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics.RESPONSIBILITIES:Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelinesEstablish and maintain effective project/ site communicationsCreate and maintain relevant project documentsEnsure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific informationParticipate in document management (creation, review, maintenance, storage, as applicable)REQUIRED KNOWLEDGE, SKILLS AND ABILITIESGood knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelinesStrong written and verbal communication skills including good command of English languageResults and detail-oriented approach to work delivery and outputGood problem solving skillsGood planning, time management and prioritization skillsAttention to detail and accuracy in workGood software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPointAbility to establish and maintain effective working relationships with coworkers, managers and clients.Proven ability to work on multiple projects balancing competing prioritiesAbility to coach/ mentor junior colleaguesClinical research associates (CRAs) organise and administer clinical trials of new or current drugs in order to assess the benefits and risks of using them.Clinical research associates help to organise and monitor the different phases of clinical trials of drugs. Key responsibilities include:
Keyskills :
clinicaltrials datacollection clinicalresearchassociates clinicalresearch ich-gcpguidelines clinicalpractices rugtrial