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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