[Hiring] Senior Clinical Research Associate / CRA II @Parexel

Role Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

• Contributes to the selection of potential investigators.
• Accountable for study start-up and regulatory maintenance, including:
  • Site Qualification Visits
  • Collection, preparation, review, and tracking of documents for the application process
  • Submission of proper application/documents to EC/IRB and Regulatory Authorities
• Trains, supports, and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required training, including ICH-GCP training.
• Ensures sites are always inspection ready.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to National Investigators meetings, as applicable.
• Initiates, monitors, and closes study sites in compliance with Client Procedural Documents.
• Shares information on patient recruitment and study site progress within the LST.
• Drives performance at the sites and proactively identifies and resolves study-related issues.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Manages study supplies and drug accountability at study sites.
• Performs monitoring visits (remote and onsite) as per the Monitoring Plan.
• Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV).
• Conducts regular Site Quality Risk Assessments and adapts monitoring intensity accordingly.
• Ensures timely data query resolution.
• Works with data management to ensure robust quality of collected study data.
• Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
• Prepares and finalizes monitoring visit reports in CTMS.
• Follows up on outstanding actions with study sites.
• Escalates systematic or serious quality issues as required.
• Assists site in maintaining inspection-ready ISF.
• Prepares for and collaborates with audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Supports/participates in regular QC checks performed by LSAD or delegate.
• Ensures all study documents are available for final archiving and completion of local part of the eTMF.
• Provides feedback on research-related information useful for the local market.
• Collaborates with local Medical Scientific Liaisons (MSLs) as directed.

Compliance with Sponsor Standards:

• Ensures compliance with the Client’s Code of Ethics and company policies.
• Ensures compliance with local, national, and regional legislation.
• Completes timesheets accurately as required.

Qualifications

• Excellent attention to detail.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Proficient in written and spoken English.
• Fluency in local language(s).

Requirements

• Ability to work in an environment of remote collaborators.
• Manages change with a positive approach.
• Ability to look for and champion more efficient methods/processes.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks.
• Ability to understand the impact of technology on projects.
• Team-oriented and flexible; ability to respond quickly to shifting demands.

Knowledge and Experience

• Excellent knowledge of international guidelines ICH-GCP.
• Basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
• Basic understanding of the drug development process.
• Good understanding of Clinical Study Management.

Education

• Bachelor’s degree in related discipline, preferably in life science.

Other

• Ability to travel nationally/internationally as required.
• Valid driving license per country requirements, as applicable.