Thermo Fisher Scientific Hiring BSc Candidates For Clinical Research Associate Job

CRA Job Opening for BSc Candidates at Thermo Fisher Scientific

CRA Job Opening for BSc Candidates at Thermo Fisher Scientific. Clinical Research Associate CRA Job Opening for BSc Candidates at Thermo Fisher Scientific. Interested Candidates can check out the details below and Apply Online

Job title: CRA (Level I)

Job Location: Mumbai, India

Job id: 226037

Job Category: Clinical Research

Job Type: Full Time

Clinical Research Associate CRA Job Opening for BSc Candidates at Thermo Fisher Scientific.

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.

Job 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 teams through 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

Working Environment:  

PPD values the health and wellbeing of our employees. They support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.

APPLY ONLINE

CRA Job Opening for BSc Candidates at Thermo Fisher Scientific. Here are five interview questions and sample answers:

1. Question: How do you ensure compliance with the protocol, ICH-GCP guidelines, and applicable regulations during clinical site monitoring visits? Answer: During site monitoring visits, I apply a risk-based monitoring approach, which involves critical thinking and root cause analysis to identify any site processes failure and potential risks. I review source documents, perform source data verification, and conduct physical inventory checks of investigational products to ensure data accuracy and protocol adherence. I document my observations promptly using approved business writing standards and escalate any deficiencies or issues to clinical management for prompt resolution.

2. Question: How do you maintain effective communication between investigative sites, the client company, and internal project teams? Answer: I believe effective communication is crucial for successful clinical trials. I facilitate communication through written, oral, and electronic channels. I maintain regular contact with investigative sites between monitoring visits to ensure ongoing protocol compliance and issue resolution. Additionally, I participate in investigator meetings when necessary to ensure clear communication with all stakeholders. I respond promptly to company, client, and regulatory requirements, including audits and inspections, to maintain transparent communication throughout the trial process.

3. Question: Describe your approach to managing risk-based monitoring concepts and processes in clinical trials. Answer: Managing risk-based monitoring requires a thoughtful and proactive approach. I prioritize critical thinking and in-depth investigation to identify potential risks. By analyzing data trends and site performance metrics, I focus my monitoring efforts on high-risk areas, enabling more efficient use of resources. Throughout the trial, I maintain a collaborative relationship with investigative sites to address any issues and provide guidance on best practices. This approach allows for adaptive monitoring strategies to mitigate risks and ensure trial integrity.

4. Question: How do you handle administrative tasks while managing your monitoring responsibilities? Answer: I understand the importance of timely and accurate administrative tasks. I ensure that I complete tasks such as expense reports and timesheets promptly to maintain project efficiency. I also maintain thorough and organized documentation of my monitoring activities to provide clear progress reports to the project team. By managing administrative tasks efficiently, I can focus more on site monitoring and other essential project-related activities.

5. Question: Can you provide an example of a situation where you encountered a challenging issue during a monitoring visit and how you resolved it? Answer: During a monitoring visit, I discovered that a site was not properly documenting adverse events as per the protocol requirements. Instead of immediately escalating the issue, I engaged in open communication with the site staff and conducted a thorough review of their procedures. I found that the site had misinterpreted the reporting requirements. To address the issue, I organized a training session for the site staff on proper adverse event documentation and reporting. I followed up with the site to ensure they implemented the correct procedures and conducted a re-visit to verify their compliance. By taking a proactive approach and fostering a collaborative environment, we successfully resolved the issue and improved the site’s performance in subsequent visits.

Editor’s Note: CRA Job Opening for BSc Candidates at Thermo Fisher Scientific. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.