BSc Life Sciences CRA
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BSc Life Sciences CRA (Level I) Job at Thermo Fisher Scientific, Apply Online

BSc Life Sciences CRA (Level I) Job at Thermo Fisher Scientific, Apply Online. Thermo Fisher Scientific CRA (Level I) vacancy for BSc Life Sciences candidates. Interested and eligible applicants can check out all of the details on the same below

Don’t forget to check out possible interview questions for this job below

CRA (Level I)

Location:  Mumbai, Maharashtra, India

Job ID: R-229536

Job Description

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site management process. At PPD we hire the best, develop ourselves and each other, and

recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose: Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites.

Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions:

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.
  • Documents observations in reports and letters in a timely manner using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
  • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  • Conducts monitoring tasks in accordance with the approved monitoring plan.
  • Participates in the investigator payment process.
  • Ensures a shared responsibility with other project team members on issues/findings resolution.
  • Investigates and follow-up on findings as applicable.
  • Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Facilitates effective communication between investigative sites, the client company and internal project teamsthrough written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
  • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner.
  • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.

Education and Experience:

  • Bachelor’s degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
  • Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered.
  • Valid driver’s license where applicable. 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.

Knowledge, Skills and Abilities:

  • Basic medical/therapeutic area knowledge and understanding of medical terminology
  • Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents
  • Good oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Good interpersonal skills
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
  • Good organizational and time management skills
  • Ability to remain flexible and adaptable in a wide range of scenarios
  • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
  • Ability to manage Risk Based Monitoring concepts and processes
  • Ability to work in a team or independently as required
  • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
  • Good English language and grammar skills

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💡 Here are a few possible interview questions for the above job posting and their answers.

👍We hope this helps in giving you a rough idea as to how to prepare for the interview for this specific role. Good luck!

  1. Can you explain your experience in clinical monitoring and site management? How have you applied a risk-based monitoring approach to identify site processes failures and implement corrective/preventive actions?

Answer: In my previous role as a CRA, I have gained extensive experience in clinical monitoring and site management. I have successfully applied a risk-based monitoring approach by conducting thorough assessments of site processes. By utilizing critical thinking and problem-solving skills, I identified any failures or deviations from protocols and promptly took corrective actions. This approach helped me ensure compliance, decrease risks, and maintain the integrity of clinical trials.

  1. How do you ensure data accuracy in clinical trials? Describe your approach to source document review, source data verification, and case report form (CRF) review.

Answer: Data accuracy is crucial in clinical trials, and I prioritize it through various methods. During site visits, I conduct thorough source document reviews to verify the accuracy and completeness of data. I also perform source data verification (SDV) to cross-check data between source documents and the CRFs. Additionally, I carefully review the CRFs for any discrepancies or missing information. By implementing these measures, I ensure data accuracy and maintain the highest standards of data integrity.

  1. Can you provide an example of a situation where you escalated observed deficiencies and issues to clinical management? How did you follow through to ensure resolution?

Answer: In a previous study, I observed deficiencies at a site related to protocol compliance. I immediately escalated the issues to the clinical management team, providing them with detailed reports. To ensure resolution, I actively followed up on the progress of addressing these deficiencies. I maintained regular communication with the site and collaborated with the clinical management team to implement corrective actions. By maintaining open lines of communication and diligent follow-up, I successfully resolved the issues and ensured compliance with protocols.

  1. How have you contributed to investigator meetings and the initiation of clinical trial sites? Explain your role in ensuring compliance with protocols, regulatory requirements, and ICH GCP obligations during site initiation.

Answer: As a CRA, I have actively participated in investigator meetings and played a crucial role in the initiation of clinical trial sites. During these meetings, I collaborated with the client company to identify potential investigators and ensure the selection of qualified investigative sites. I facilitated the initiation process, ensuring compliance with protocols, regulatory requirements, and ICH GCP obligations. By conducting thorough reviews and making recommendations, I ensured that sites were equipped to conduct the trial in accordance with the highest standards.

  1. Describe your experience in maintaining effective communication between investigative sites, the client company, and internal project teams. How have you handled written, oral, and electronic contacts to address company, client, and regulatory requirements?

Answer: Communication is key in clinical trials, and I have excelled in maintaining effective communication channels. I have consistently communicated with investigative sites, the client company, and internal project teams through various mediums such as written reports, oral discussions, and electronic correspondence. I have ensured timely responses to address company, client, and regulatory requirements. By actively listening, paying attention to detail, and responding promptly, I have fostered productive and collaborative relationships with stakeholders, facilitating the smooth progress of clinical trials.

Please note that these sample answers are meant to provide a general idea and should be personalized based on the candidate’s actual experiences and skills.

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