Clinical Trial Associates / Sr. Clinical Trial Associates (2)

Description:

Why join Cardurion Pharma?

At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing our drug candidates to improve health outcomes and impact lives around the world.

The Roles:

We are seeking two highly motivated, goal-oriented team players to join Cardurion’s Clinical Operations team as Clinical Trial Associates (CTA) / Senior Clinical Trial Associates (Sr. CTA). CTA/ Sr. CTA supports clinical studies and the Clinical Operations Department in managing various organizational tasks such as generation of agendas and minutes, maintaining study tracking, filing and quality reviews as well as participating in process improvement initiatives across the department. This position will report to the relevant study-specific Sr. Director/Director of Clinical Operations. The CTA / Sr. CTA will play a key role in working cross functionally to support the clinical teams including close collaboration with cross-functional Cardurion team members and team members from vendors and CROs in completing all required tasks to meet departmental and project goals.

The preferred location for this role is hybrid-based out of Burlington, MA; will consider remote candidates.

Here’s What You’ll Do:

• Responsible for day-to-day operational management of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements
• Supports the multidisciplinary clinical study team and collaborates with other functions as required for implementation and execution of the study(s)
• Contributes to the development of study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and tools, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
• Contributes to study dashboards and metrics reports, as appropriate.
• Assist in vendor oversight activities, such as tracking activities, collecting metrics and filing documents.
• Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File)
• Conducts routine reviews of key trial operational deliverables including, but not limited to monitoring report review, TMF status and completeness checks, maintenance of study team training records.
• Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials
• Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate

Requirements:

Here’s What You’ll Bring to the Table:

Core Competencies

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction
• Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines
• Must have excellent interpersonal, written and verbal communication skills
• Skilled in developing collaborative internal and external relationships
• Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

Qualifications

• Requires a relevant scientific or health related field Bachelor’s degree with at least 2 years of relevant work experience in a pharmaceutical or biotechnology or CRO environment
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
• Experience in managing CROs and external vendors
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus
• Some travel may be expected for this position including internal meetings, conferences or training events

Here’s What We’ll Bring to the Table:

• Highly competitive package with healthcare coverage including medical, dental and vision
• Fully funded Healthcare Savings Account for high-deductible PPO Plan
• 4 weeks paid time off annually
• 10 company paid holidays and year-end shut down
• 401k (traditional and Roth offered) with company match
• A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability
• Flexible spending accounts for medical and dependent care expenses

Our Mission:Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.