Clinical Trial Associate

Description

Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

The Role:

We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Clinical Trial Associate (CTA) supporting clinical studies and the Clinical Operations Department in managing various organizational tasks such as maintaining the Trial Master File, preparing agendas, minutes, and tracking logs, filing and quality reviews under the supervision of the CTM and Clinical Operations Program lead. The successful candidate will participate in process improvement initiatives across the department. This position will report to the relevant study-specific Director or Program Lead of Clinical Operations. This role is required to be onsite in Burlington office 3 days a week.

Here’s What You’ll Do:

• •Supports day-to-day operational management of assigned clinical studies including study start-up, conduct, and close-out activities under the direction of the study CTM or study Director.
• •Reviews and QC-checks TMF documents; tracks monitoring report receipt and training records.
• •Track vendor deliverables, collects metrics and files documents.
• •Supports the multidisciplinary clinical study team with logistics and follow-up; communicates with CRO/ vendor counterparts on routine logistics, as appropriate.
• •Assists with formatting, version control, QC and distribution of study documents and plans.
• •Maintains study trackers to support tracking of study progress to plan (ex: site-start-up, enrollment, supplies).
• •Reviews study document templates and site-specific adaptations, including ICFs and patient recruitment materials.
• •Supports the logistics of developing study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and tools, CRF Completion Guidelines, Clinical Study Report (CSR), and submission documentation, as appropriate, including plans developed by the CRO where applicable.
• •Assist in coordination of DMC and other committees as needed.
• •Schedules internal team meetings; prepares agendas, minutes and action-item logs; supports investigator meeting and other study-specific meeting logistics, as appropriate.
• •Provides input on SOPs and templates, as appropriate.
• •Manages study system access and user requests.

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

Pay Range: $95,000 - $105,000

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 with guidance from the CTM or Director.
• •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

• •Bachelor’s degree in a scientific or health-related field, or equivalent experience
• •At least 1 year of clinical operations or trial support experience at a Sponsor, or at least 2 years at a CRO.
• •Working knowledge of ICH-GCP, and familiarity with eTMF and CTMS systems.
• •Exposure to CRO and vendor coordination in an outsourced Clinical Trial structure.
• •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

Our Mission: Translate our world-class expertise in cardiovascular signaling pathways into potentially 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.