Senior Clinical Research Associate/Clinical Research Associate - FSP

Parexel is actively hiring multiple Clinical Research Associates and Senior Clinical Research Associates to join their growing team. The CRA is responsible for the delivery of studies at allocated sites, ensuring compliance with international guidelines and local regulations while managing site performance and study conduct.

Responsibilities

Contributes to the selection of potential investigators

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the 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. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate

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. Prepares study drug for destruction, if applicable

Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits

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, 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

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)

Ensures compliance with local, national, and regional legislation, as applicable

Completes timesheets accurately as required

Complies with required training curriculum

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

Company

Global clinical research and biopharmaceutical services company

Raleigh, North Carolina, USA

http://www.parexel.com/

Founded in 1983

10001+ employees

Qualifications

Proficient in written and spoken English language required

Fluency in local language(s) required

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

3+ years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position and 1+ years of experience for the Clinical Research Associate role

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

Ability to travel nationally/internationally as Required

Glassdoor

3.8

Global clinical research and biopharmaceutical services company.

Raleigh, North Carolina, USA

http://www.parexel.com

H1B Sponsorship

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Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Education and Training

Engineering and Development

Management and Executive

Accounting and Finance

Legal and Compliance

Customer Service and Support

Sales

Marketing

Human Resources

Trends of Total Sponsorships

*2026

(38)

2025

(31)

2024

(46)

2023

(41)

2022

(51)

2021

Required skills

ICH-GCP, GMP, GDP, Clinical Study Management, Study Monitoring, Study Drug Handling, Data Management, Clinical Research, Therapeutic Area Knowledge, Local Language Fluency

Experience

1+ years