Clinical Research Associate/Senior Clinical Research Associate- FSP

About the role

Parexel FSP is seeking a Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA) based in the US. The ideal candidate must have oncology experience and cell therapy experience is preferred.

Key Accountabilities

• Contributes to the selection of potential investigators.
• 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.
• Actively participates in Local Study Team (LST) meetings.
• Ensures that study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site are managed.
• Performs monitoring visits (remote and onsite), as well as remote data checks, 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.
• Updates CTMS and other systems with data from study sites as per required timelines.
• Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate.
• 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, including follow-up letter, within required timelines and in line with Client SOP.
• 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, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance 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 in liaison with LSAD and Clinical Quality Associate Director (CQAD).
• 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 (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF.
• Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
• Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager.

Compliance with Sponsor and Parexel Standards

• Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment).
• Completes timesheets accurately as required.
• Submits expense reports as required.
• Updates CV as required.
• Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements.

Skills

• 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.

Education

• Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.