30+ GenXhire Interview Questions and Answers

Interim monitoring visits involve reviewing study progress and data quality.

• Reviewing study progress and data quality

• Ensuring compliance with study protocol and regulatory requirements

• Identifying and resolving issues or discrepancies

• Assessing site performance and training needs

• Communicating with study team and site staff

• Preparing monitoring reports

Essential project management skills include communication, leadership, time management, problem-solving, and organization.

• Communication: Ability to effectively communicate with team members, stakeholders, and clients.

• Leadership: Leading and motivating team members to achieve project goals.

• Time Management: Prioritizing tasks, setting deadlines, and ensuring project stays on schedule.

• Problem-Solving: Identifying issues, analyzing solutions, and making decisions to overcome chal...read more

Core configuration is the basic setup of a system, DTS is a data transformation tool, and test cases are scenarios to test system functionality.

• Core configuration includes settings such as network, security, and database configurations.

• DTS (Data Transformation Services) is a tool used to extract, transform, and load data between different systems.

• Test cases are scenarios designed to test the functionality of a system, including positive and negative scenarios.

• Test cases shoul...read more

The IRB process involves the submission and approval of research protocols.

• Researchers submit their research protocols to the Institutional Review Board (IRB) for review and approval.

• The IRB evaluates the protocol to ensure it meets ethical and regulatory standards.

• The IRB considers factors such as participant safety, informed consent, and potential risks and benefits.

• Approval from the IRB is necessary before the research can begin.

• The IRB may request modifications to the pro...read more

AP cycle is Accounts Payable cycle which involves processing of vendor invoices and making payments. P2P cycle is Procure to Pay cycle which involves procurement of goods and services and making payments.

• AP cycle includes receiving invoices, verifying them, recording them in the system, and making payments to vendors.

• P2P cycle includes identifying the need for goods or services, selecting vendors, creating purchase orders, receiving goods or services, verifying them, and maki...read more

A records management specialist is responsible for organizing, maintaining, and disposing of records in an efficient and secure manner.

• Develop and implement records management policies and procedures

• Ensure compliance with legal and regulatory requirements

• Organize and maintain physical and electronic records

• Dispose of records in accordance with retention schedules

• Train employees on proper records management practices

• Conduct audits to ensure adherence to policies and procedures

Proper documentation is crucial in clinical research to ensure accuracy, transparency, and compliance with regulations.

• Documentation should be detailed, accurate, and timely

• All data should be recorded and maintained in a secure and organized manner

• Documentation should be compliant with regulatory requirements and guidelines

• Proper documentation allows for replication of the study and verification of results

• Examples of documentation include informed consent forms, case report f...read more

Clinical protocol is a set of guidelines outlining the objectives, design, methodology, and organization of a clinical trial.

• Clinical protocol is a detailed plan that specifies how a clinical trial will be conducted.

• It includes information on the study objectives, design, methodology, statistical considerations, and organization.

• Deviation window refers to the acceptable range of time within which a deviation from the protocol is still considered valid.

• IE form stands for 'Inve...read more

SDTM classes are used to standardize clinical trial data. Examples include DM, AE, and LB domains.

• SDTM classes are used to organize data into standardized domains

• DM (Demographics) domain includes information about study subjects

• AE (Adverse Events) domain includes information about any adverse events experienced by study subjects

• LB (Laboratory) domain includes laboratory test results

• Other examples of SDTM domains include EX (Exposure), VS (Vital Signs), and CM (Concomitant Med...read more

CDISC standard includes data models, controlled terminology, and implementation guides.

• CDISC stands for Clinical Data Interchange Standards Consortium.

• CDISC standards ensure consistency and interoperability of clinical trial data.

• CDISC includes data models such as SDTM and ADaM, controlled terminology, and implementation guides.

• SDTM (Study Data Tabulation Model) is used for organizing and submitting data from clinical trials.

• ADaM (Analysis Data Model) is used for analysis of ...read more

ICON Plc values include integrity, excellence, collaboration, innovation, and patient focus.

• Integrity: Upholding high ethical standards in all interactions

• Excellence: Striving for quality and continuous improvement

• Collaboration: Working together to achieve common goals

• Innovation: Embracing creativity and new ideas

• Patient focus: Putting the needs of patients at the center of everything

Budgeting involves setting financial goals and allocating resources, while forecasting involves predicting future financial outcomes based on current data.

• Budgeting is the process of creating a detailed plan for the future that outlines expected revenues and expenses.

• Forecasting involves using historical data and trends to predict future financial outcomes.

• Budgeting is more focused on setting financial targets and allocating resources accordingly, while forecasting is about p...read more

Classification of drugs refers to grouping of drugs based on their chemical structure, mechanism of action, and therapeutic use.

• Drugs can be classified based on their chemical structure, such as opioids, benzodiazepines, and beta blockers.

• They can also be classified based on their mechanism of action, such as antihypertensives, anticoagulants, and antibiotics.

• Therapeutic classification groups drugs based on their intended use, such as analgesics, antidepressants, and antipsyc...read more

3 way matching is a process of matching three documents - purchase order, invoice and receiving report - to ensure accuracy of payment.

• Three documents - purchase order, invoice and receiving report - are matched to ensure accuracy of payment.

• The purchase order is matched with the receiving report to confirm that the goods have been received.

• The invoice is matched with the purchase order and receiving report to confirm that the goods have been received and the price is correct...read more

I have experience in clinical trial management and can provide a descriptive answer.

• Clinical trials are research studies that test the safety and effectiveness of new drugs, treatments, or medical devices.

• They are conducted to gather data and evidence to support regulatory approval and improve patient care.

• Clinical trial specialists play a crucial role in coordinating and managing various aspects of the trial, including recruitment, data collection, and compliance with regula...read more

An accrual entry is a journal entry made to record revenue or expenses that have been earned or incurred, but have not yet been received or paid.

• Accrual entries are used to match revenues and expenses to the period in which they are earned or incurred, regardless of when the cash is actually received or paid.

• For example, if a company provides services in December but does not receive payment until January, an accrual entry would be made in December to recognize the revenue.

• Ac...read more

Icon plc is a global leader in clinical research services, offering a diverse range of opportunities for professional growth and development.

• Icon plc has a strong reputation in the industry for delivering high-quality services and innovative solutions.

• The company offers a wide range of projects and clients, providing a diverse and challenging work environment.

• Icon plc values employee development and offers opportunities for career advancement and training.

• Working at Icon plc ...read more

I have 2 years of experience in clinical research and have successfully managed multiple tasks simultaneously.

• I have conducted patient interviews, collected data, and assisted in data analysis for clinical research studies.

• I have experience in managing study timelines, coordinating with study sites, and ensuring compliance with protocols.

• I am proficient in handling multiple tasks efficiently, prioritizing workload, and meeting deadlines.

• For example, in my previous role as a R...read more

Test cases ensure software quality. UAT examples validate user requirements.

• Test cases are designed to verify the functionality of software.

• UAT examples are used to validate user requirements and ensure the software meets their needs.

• Test cases should cover all possible scenarios and edge cases.

• UAT examples should be based on real-world scenarios and user workflows.

• Both test cases and UAT examples should be documented and tracked for future reference.

To update salary, use SQL UPDATE statement with SET clause and WHERE clause to specify the salary to be updated.

• Use UPDATE statement with SET clause to specify the new salary value

• Use WHERE clause to specify the condition for which salary to update

• Example: UPDATE employees SET salary = 60000 WHERE department = 'IT'

I have extensive experience with Veeva Vault in managing clinical trial documents and ensuring compliance.

• Managed document workflows within Veeva Vault for multiple clinical trials

• Ensured documents were stored securely and in compliance with regulatory requirements

• Collaborated with cross-functional teams to streamline document management processes

OS migration refers to the process of upgrading or transferring an operating system to a newer version or different hardware.

• OS migration involves transferring data, applications, and settings from one operating system to another.

• It may require hardware and software compatibility checks and updates.

• Migration can be performed manually or using automated tools.

• Examples include upgrading from Windows 7 to Windows 10 or migrating from macOS to Linux.

• Migration may involve testing ...read more

Icon is a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries.

• Icon offers a range of services including clinical trial management, data management, biostatistics, pharmacovigilance, and regulatory consulting.

• The company has offices in over 40 countries and works with clients across the globe.

• Icon has a strong reputation for delivering high-quality, reliable services to support the development of new healthcare...read more

I have extensive experience in source writing for clinical research studies.

• I have written source documents such as case report forms, study protocols, and informed consent forms.

• I ensure accuracy, clarity, and compliance with regulatory guidelines in all source writing.

• I have experience in collaborating with cross-functional teams to develop and review source documents.

• I am proficient in using electronic data capture systems for source writing and data management.

Proficient in using EDC tools for data collection and management in clinical research.

• Experience with various EDC systems such as Medidata Rave, Oracle InForm, and REDCap

• Ability to design electronic case report forms (eCRFs) and manage data entry

• Knowledge of data validation checks and discrepancy management

• Experience in generating reports and analyzing data for clinical trials