Clinical Research Associate Jobs

Position: Clinical Research Associate

Location: Cambridge, MA (Remote)

Length: 6 months

Covid Requirements: N/A

:

Our client is looking for a Clinical Research Associate to provide support for study management tasks in collaboration with the Lead Clinical Research Associate and Clinical Operations team with an emphasis on monitoring oversight activities for the Clinical Research Organizations (CROs). The Clinical Research Associate will work with clinical to assure that protocol requirements, laboratory collections, regulatory guidelines, and timelines are met.

Essential Duties and Responsibilities (but not limited to):

• Collaborate with the CRO counterpart.
• Lead the trial master file processes.
• Serve as a representative to CRO, study vendors, and site staff.
• Performs clinical oversight of study site management and monitoring activities in compliance with ICH-GCP, SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents.
• Track clinical supply shipments and manage shipment logistics.
• Attend qualification and site initiation visits.
• Review monitoring visit reports from the CRO.
• Track metrics related to sponsor oversight and the monitoring plan.
• Roughly 80% travel to sites throughout the United States.
• Participate in investigator meeting planning.
• Monitor studies or perform co-monitoring visits as required per the Sponsor Oversight Plan or as needed.
• Assist the Clinical Trial Manager in the review of ICFs and essential documents.

Qualifications:

• Knowledge of electronic data capture and other IT systems (CTMS, Microsoft Office, etc.)
• Bachelor’s degree in a scientific discipline.
• Good understanding of Global, Country, and Regional Clinical Research Guidelines and ability to work within these guidelines.
• Ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP, ICH, and country clinical research law and guidelines.
• Excellent interpersonal skills with the ability to develop important relationships with key stakeholders across a variety of disciplines.
• Good conflict management and negotiation skills.
• Thrives in a fast-paced and evolving environment.
• Strong communication skills both verbally and written in English.
• Minimum of 2-3 years demonstrated site monitoring experience in a biotechnology, pharmaceutical, and/or CRO company.
• Certification as a Clinical Research Associate or Clinical Research Professional is highly desirable.
• Highly organized and outcome oriented with self-motivated performance.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Make this your next career move as one of our many long-term contractors or employees!

• Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

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Job #16017