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About Company

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

Position Name :

assistant CRA

Organization :

Thermo Fisher Scientific

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

0 YEARS / Freshers - 2 Years

Salary:

4.1 to 7.1 Lacs

Location:

Work From Home

  • Perform remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA, and study CTM.
  • Provide support for site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
  • May be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.

Key Responsibilities:

  • Complete study and site management activities as defined in task matrix, and as applicable and advised for the study assigned.
  • Complete and document study-specific training.
  • Orient and train on any CRG/study-specific systems.
  • Provide in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for the project.
  • Support the customization of Site ICF with site contact details, as needed.
  • Perform remote review of EMR/EHR checklist and support collection, as applicable.
  • Verify document collection and RCR submission status; update site EDL and verify site information.
  • Review patient-facing materials and translations, as directed.
  • Support site staff with the vendor-related qualification process, where applicable.
  • Ensure system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
  • Follow-up on site staff training, as applicable.
  • Coordinate and support logistics for IM attendance, as advised.
  • Maintain vendor trackers, as advised.
  • Coordinate study/site supply management during pre-activation and subsequent course of the study.
  • Collect, review, and update crucial documents in systems, as applicable.
  • Follow up on missing study vendor data like ECGs, lab samples, and e-diaries, as advised.
  • Support ongoing remote review of centralized monitoring tools, as advised.
  • Coordinate with various functional departments and sites for site payment processes.
  • Perform reconciliation tasks on assigned trials, including but not limited to CRF and query status, deviations, SAEs, and safety reports, as applicable.
  • Verify document collection status in CRG systems and drive action for missing/incomplete/expired documents and open document findings, as advised.
  • Perform other assigned site management tasks as directed by RCRA and as per Task Matrix.
  • May perform a specific role profile for FSP opportunities according to Client requests.
  • Complete administrative tasks such as expense reports and timesheets in a timely manner.

Education and Experience:

  • Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).

Knowledge, Skills, and Abilities:

  • Basic medical/therapeutic area knowledge and understanding of medical terminology.
  • Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations, and CRG procedural documents.
  • Effective oral and written communication skills.
  • Excellent interpersonal and customer service skills.
  • Good interpersonal and time management skills, with strong attention to detail.
  • Proven flexibility and adaptability.
  • Ability to work in a team or independently, as the need arises.
  • Well-developed critical thinking skills, including critical mindset, in-depth investigation for root cause analysis, and problem-solving.
  • Proficient digital literacy with good knowledge of MS Office and the ability to learn and use appropriate software.
  • Ability to extract pertinent information from all study documents, electronic study data systems, CTMS, and dashboards.
  • Excellent English language and grammar skills.

Application Link

10 thoughts on “[WFH + Freshers] Thermo Fisher Scientific Hiring in Clinical Research”

  1. Hi mam/ sir
    Hope doing great
    My name is Geetanjali Dadasaheb Raut recently I have completed my B pharm and right now i am looking entry level job in innovative organisation like yours
    I’m immediate joiner.

  2. Hello Sir/Ma’am,
    I’m Aastha Jaiswal,B.pharm graduated student and right now looking for job in phrmacovigilance. I’m immediate joiner with excellent Communication skills.
    Email address:aasthajsswl@gmail.com.

  3. Hello Sir/ Ma’am,
    Myself Aashirwad Kailash Mor and I’m interested for doing this job
    I recently completed my degree and I am looking for the job in the superficial as well as well established organisation and the expert team like you

  4. Hi mam/ sir
    Hope doing great
    My name is Kiran Rajput I have completed my MSc in Clinical Research.

    Having worked with Hospitals sites. I have 3 year of experience as Clinical Research Coordinator. I handled phase- III and phase-IV clinical trials.
    my experience in Clinical trial management includes Good Clinical Practice (GCP), Skilled in Electronic Data Capture (EDC), Data management, Investigator Site file (ISF), Subject file Documentation, Time Management, Maintain logs, Work with PI and daily clinical trials activity, Notification of SAE reporting with timelines, Patient pre-screening, Recruitment, follow-up, Data entry, query resolution, investigational product management, dispensing, time management, Monitoring Visits like SDV SMV & Remote SDV.

    I am looking for Clinical Research associate / assistant CRA

  5. Hi mam/ sir
    Hope doing great
    My name is Suraj sambhaji patil I am B pharm student and right now i am looking entry level job in innovative organisation like yours
    I’m immediate joiner.

  6. Hello Sir/Mam
    I am Ankita Thorat and I am looking for this kind of job.
    I have recently completed my B Pharmacy.
    I am interested in this job and ready for immediate joining.

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