Parexel CRA Job For Biological Sciences, Apply Online
Parexel CRA Job For Biological Sciences, Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Clinical Research Associate
Location: Bengaluru, India
Job ID: R0000032449
Category: Clinical Trials
Date Posted: 03/27/2025
About This Role
Key Accountabilities:
Maintenance (from initiation through closeout):
● Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
● Build relationships with investigators and site staff.
● Facilitate and support site with access to relevant study systems and ensure sites are compliant with project-specific training requirements.
● Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary/relevant.
● Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
● Address/evaluate/resolve issues pending from the previous visit, if any.
● Follow up on and respond to appropriate site-related questions.
● Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
● Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
● Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
● Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
● Perform on-site visits, including Qualification and Initiation visits, and apply judgment and knowledge to independently resolve site issues, questions, and concerns.
● Conduct remote visits/contacts as requested/needed.
● Generate visit/contact reports.
● Evaluate overall compliance and performance of sites and site staff; provide recommendations regarding site-specific actions and assess the ability and motivation of site staff.
● Assess & manage test article/study supply including supply, accountability, and destruction/return status.
● Review & follow up on site payment status.
● Follow up on CRF data entry, query status, and SAEs.
● Conduct on-site study-specific training (if applicable).
● Perform site facilities assessments.
● Recognize the impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with a proposed strategy for resolution.
Overall Accountabilities from Site Identification to Closeout:
● Ensure timely and accurate completion of project goals and update applicable trial management systems.
● Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
● Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis.
● Perform regular reviews of site-level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high-quality data entry compliance from sites.
● Manage and submit all relevant documents to the Trial Master File (TMF), ensuring first-time quality.
● Distribute study documents to sites, including configuration of Investigator Site Files if applicable, and ensure ongoing maintenance for completeness and quality.
● Ensure that assigned sites are audit and inspection-ready.
● Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
● Delegate administrative and other tasks to the Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to the manager regarding performance.
● Show commitment and perform consistently high-quality work.
● Maintain a positive, results-oriented work environment, building partnerships and collaborative relationships, communicating with teams in an open, balanced, and objective manner.
● Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel/Sponsor training requirements, and study-specific procedures, plans, and training.
● Ensure a basic understanding of project scope, milestones, and budgets, striving for high-quality, timely, and efficient delivery.
● Provide input and feedback for Performance Development Conversations.
● Proactively keep the manager informed about work progress and any issues.
● Develop expertise to become a subject matter expert.
● Work in a self-driven capacity, with limited need for oversight.
● Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.).
Skills:
● Sound problem-solving skills.
● Able to take initiative and work independently, and proactively seek guidance when necessary.
● Advanced presentation skills.
● Client-focused approach to work.
● Ability to interact professionally within a client organization.
● Flexible attitude with respect to work assignments and new learning.
● Ability to prioritize multiple tasks and achieve project timelines; utilize strong analytical skills to make decisions autonomously due to the unpredictable nature of issues that arise.
● Willingness to work in a matrix environment and value the importance of teamwork.
● Strong computer skills including, but not limited to, Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office products such as Excel and Word.
● Strong interpersonal, verbal, and written communication skills.
● Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables while preserving patient safety.
● Effective time management to meet study needs, team objectives, and department goals.
● Developing ability to work across cultures.
● Shows commitment to and performs consistently high-quality work.
● Ability to successfully work in a (‘virtual’) team environment.
● Consulting skills.
● Great attention to detail.
● Able to accommodate extensive travel time requirements, according to task allocation/phase of the study assigned.
● Holds a driver’s license where required.
Knowledge and Experience: Site Management experience or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.
Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
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