Clinical Trial Associate - Hybrid Remote and On Site in Cambridge, MA - FSP

Parexel is hiring a Clinical Trial Associate to support a key biotech sponsor in FSP. This is a Hybrid position which will require working in the client's office in Cambridge, MA 2 days per week.

Job Summary:

The Clinical Trial Associate (CTA) is responsible for assisting clinical study teams in the execution of clinical trials and on-time delivery of clinical trial deliverables.

Key Accountabilities:

Oversight and Project/Study Support

• Assist with the in-house coordination of activities related to the conduct of clinical trials
• Track progress across multiple programs and communicate this to internal and external stakeholders
• Assist in maintaining clinical invoice tracking and other budget databases for multiple projects; generate periodic reports on status of payments and other database reports, and resolve payment inquiries from investigator sites
• Maintain informational databases for clinical trial status throughout the life of a clinical program
• Responsible for the assembly, review, quality control, and tracking of regulatory documents
• Perform maintenance and tracking of study materials including investigational drug
• May be responsible for authoring study operations manuals
• Receive guidance on clinical development process and the role operations plays in the process

Project Meeting Support

• Organize trial and program related team meetings, associated agendas, and generate meeting minutes, including tracking of action items

Project Meetings:

• Supports preparation of required information for various project meetings
• Reporting of owned responsibilities during meeting attendance
• Support tracking and follow-up of action items.
• Distributes agendas prior to meetings, and prepares and distribute minutes of internal and client meetings
• Promotes communication among team members

Compliance with Parexel Standards:

• Complies with required training curriculum
• Completes timesheets accurately and timely as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Skills:

• Ability to effectively and efficiently interact with internal, clinical site, and vendor personnel
• Ability to learn health care authority regulations and guidelines and apply to daily activities
• Has the interest and ability to expand knowledge of clinical trial management procedures and regulatory submission requirements
• Ability to learn and execute defined tasks while working closely with others
• Demonstrates problem-solving skills, including the identification of problems and proposes solutions, in consultation with more senior team members
• Possesses good verbal skills and seek information when needed
• Seeks opportunities to learn and be receptive to constructive feedback
• Ability to work independently
• Ability to travel as needed (less than 20% for non-monitoring related work)
• Proficiency in written and spoken English required
• Proficiency in local language as applicable

Knowledge and Experience:

• Minimum 1 year work experience in related field
• Experience working in Contract Research Organization (CRO) and/or clinical trial environment is required
• Experience supporting regulatory document collection is required
• Familiarity with GCP/ICH guidelines is required

Education:

• Bachelor of Science (BS)/Bachelor of Arts (BA) degree in healthcare/scientific field required

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.