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Clinical Research

Job Location:  Kolkata
Job Description:  SkillSet: "data collection", "drug trial", "clinical practices", "clinical research associates", "clinical trials".

Experience 0 to 1 year Freshers can Apply

Skills 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 timelines
Establish and maintain effective project/ site communications
Create and maintain relevant project documents
Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
Participate in document management (creation, review, maintenance, storage, as applicable)

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good knowledge of applicable clinical research regulatory requirements; i.e., ICH GCP and relevant local laws, regulations and guidelines
Strong written and verbal communication skills including good command of English language
Results and detail-oriented approach to work delivery and output
Good problem solving skills
Good planning, time management and prioritization skills
Attention to detail and accuracy in work
Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Proven ability to work on multiple projects balancing competing priorities
Ability to coach/ mentor junior colleagues

Clinical 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:

  • writing drug trial methodologies (procedures)
  • identifying and briefing appropriate trial investigators (clinicians)
  • setting up and disbanding trial study centres
  • designing trial materials and supplying study centres with sufficient quantities
  • providing clinicians with instructions on how to conduct the trials
  • collecting and authenticating data collection forms (commonly known as case report forms)
  • monitoring progress throughout the duration of the trial
  • writing reports

Typical employers of clinical research associates

Pharmaceutical companies
Clinical contract agencies or houses
Hospital academic departments

Key skills for clinical research associates

Commercial awareness
A logical and inquisitive mind
Good organisational abilities
Excellent numerical, written and verbal communication skills
Confidence

Client : Genozyme Pharmaceuticals

Functional Area:  Medical Transcription
Experience:  0 - 3 years
Qualification: 
Salary:  3.0 Lakh to 7 Lakh INR
 
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Job Ad publication date: 03 Mar 2021  

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