[Hiring] Clinical Research Associate I/II/Senior @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 to Regulator Authorities for start-up and duration of the study
• 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 appropriately, including ICH-GCP training, prior to and for the duration of the study.
• Ensures the sites are inspection ready at all times.
• 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 (site quality/performance) within the LST.
• Drives performance at the sites and proactively identifies and ensures timely resolution to study-related issues.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Manages study supplies (Investigator Site File (ISF), etc.), drug supplies, and drug accountability at study site.
• Performs monitoring visits (remote and onsite) in accordance with the timelines specified in the study-specific Monitoring Plan.
• Performs Source Data Review (SDR), Case Report Form (CRF) review, and Source Data Verification (SDV) in accordance with the Monitoring Plan.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
• Ensures data query resolution in a timely manner.
• Works with data management to ensure robust quality of the collected study data.
• Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups.
• Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator.
• Follows up on outstanding actions with study sites to ensure resolution in a timely manner.
• Follows quality issue processes by escalating systematic or serious quality issues to Local Management and/or Clinical Quality Management (CQM) as required.
• Assists site in maintaining inspection ready ISF.
• Prepares for and collaborates with the activities associated with audits and regulatory inspections.
• Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs, and local requirements.
• Supports/participates in regular QC checks performed by LSAD or delegate.
• Ensures that all study documents under their responsibility are available and ready for final archiving and completion of local part of the eTMF.
• Provides feedback on any research-related information that might be useful for the local market.
• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.

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 language required.
• Fluency in local language(s) required.

Requirements

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

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 including monitoring, study drug handling, and data management.

Education

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

Other

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