Senior Clinical Research Associate - Remote

Parexel; Annapolis (MD); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Parexel is seeking a Clinical Research Associate (CRA) to manage investigator sites, monitor trials and support close-out in compliance with GCP and sponsor standards. You will ensure patient safety and data quality across site operations.

Responsibilities include on-site and remote monitoring, site activation through database lock, coordinating with Site Care Partner, QA, AE/SAE follow-up, and timely documentation. Travel 60-80% and require life sciences degree.

Qualifikationen

• Bachelor's degree in life sciences or equivalent (nursing, pharmacy, medical background).
• Minimum 2 years of clinical research site monitoring experience.
• Fluent in English and the local language(s) of the country you work in.
• Willingness to travel 60-80% of the time.
• Valid driver's license and passport required.

Aufgaben

• Ensure proper conduct of trials per SMP, laws, GCP and sponsor standards.
• Manage site activation through database lock with quality deliverables.
• Serve as primary contact for investigator sites; coordinate with SCP.
• Interface with study team, vendors and sites for smooth information flow.
• Provide investigator site development, training and protocol guidance.
• Attend investigator meetings and support recruitment initiatives.
• Conduct on-site and remote monitoring; ensure QA and data integrity.
• Monitor AEs/SAEs and follow up to resolution with Drug Safety Unit.
• Prepare TMF, site reports, deviations, recruitment updates and close-out plans.

Kenntnisse

Clinical trial methodologies

ICH/GCP compliance

FDA regulations

English fluency

Travel readiness

Driver's license & passport

Ausbildung

Bachelor's degree in life sciences or equivalent

Jobbeschreibung

Parexel is seeking a Clinical Research Associate (CRA) to manage investigator sites, monitor trials and support close-out in compliance with GCP and sponsor standards. You will ensure patient safety and data quality across site operations.

Responsibilities include on-site and remote monitoring, site activation through database lock, coordinating with Site Care Partner, QA, AE/SAE follow-up, and timely documentation. Travel 60-80% and require life sciences degree.