Clinical Trial Associate

Cardurion Pharmaceuticals

Burlington (MA)

Hybrid

USD 95,000 - 105,000

Full time

7 hours ago

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Benefits offered by this job

Healthcare coverage (medical, dental,视

401k with company match

Paid time off and holidays

Life insurance and disability

Job summary

Cardurion Pharmaceuticals is seeking a motivated Clinical Trial Associate to join our Clinical Operations team in Burlington, onsite 3 days a week. You will support study start-up, conduct, and close-out under the supervision of the CTM or Director, while maintaining TMF integrity and coordinating with CROs.

You will help with document formatting, version control, and trackers to monitor progress, and assist with committee coordination, templates, and access management.

Qualifications

Proven experience in clinical operations or trial support.
Familiarity with ICH-GCP and eTMF/CTMS systems.
Exposure to CRO/vendor coordination in outsourced trials.
Strong MS Office skills and document management.
Willingness to travel for internal meetings or training.

Responsibilities

Support day-to-day operational management of assigned clinical studies under CTM or Director.
QC-check TMF documents; track monitoring and training records.
Track vendor deliverables and file documents.
Coordinate logistics with CRO/vendor counterparts for study activities.
Assist with formatting, version control, and distribution of study documents.
Maintain study trackers for site start-up, enrollment, and supplies.
Review templates and site-specific adaptations (ICFs, recruitment materials).
Develop study-related documents with CRO input as applicable.
Coordinate DMC and other committees as needed.
Schedule team meetings and prepare agendas, minutes, action-item logs.
Provide input on SOPs and templates; manage study system access.

Skills

Team player

Detail-oriented

Time management

Interpersonal skills

Communication

Collaboration

Education

Bachelor’s degree in scientific/health field

Tools

MS Office

MS Project

Smartsheet

Job 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.

Job Type

Full-time

Description

Why join Cardurion Pharma?

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.

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