Senior Clinical Research Associate

Job Description :

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives.

Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our people first philosophy.

Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world s oldest enemy : disease.

With Ferring, you will be joining a recognized leader, identified as one of The World s Most Innovative Companies by Fast Company, and honored by Fortune with inclusion on its Change the World List, for addressing society s unmet needs.

Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities :

The Senior Clinical Research Associate (CRA) will act as a liaison between Ferring (the study Sponsor) and the sites / clinics that conduct their assigned clinical studies.

Focused primarily on ensuring data quality and regulatory compliance, the CRA will work closely with the Principal Investigator and their staff at their assigned clinical study sites.

The Senior CRA will identify and / or resolve data queries and will ensure identification and reporting of safety events and / or device deficiencies.

Requiring little supervision, the Senior CRA will review site files and processes to ensure that applicable regulations are being followed.

They will actively participate in site identification and qualification activities. Assigned studies tend to be larger, more complex studies used to support device registrations.

Responsibilities include, but are not limited to :

Independently build and maintain successful working relationships with internal partners and site staff (e.g., Principal Investigators, Study Coordinators)

Acts as the primary liaison between Ferring and the investigational site

Perform all types of monitoring visits (i.e., on-site, virtual / remote, in-house) including Pre-Study (Qualification), Site Initiation, Interim, and Close-Out, according to plan

Conducts source document verification per plan

Routinely performs site document reviews to ensure compliance with applicable regulations and standards (e.g., GCP / ISO, IRB / EC policies and procedures

Site interactions involve prioritization of subject safety including appropriately administered informed consent

Review / report AE / SAEs and protocol deviations per industry and standards

Maintain audit-ready regulatory files for assigned site(s) / project(s) that align with company and industry parameters

Maintain all project supporting systems, e.g. CTMS, EDC, eTMF, etc

Produce proficient and timely documentation of monitoring activities / visits (e.g., timely and complete trip reports, contact records, etc.

within company-specified quality standards)

Collaborate with the studies cross-functional team members and actively participate in meetings

Assist in development and delivery of site-facing presentation materials for Investigator Meetings, Initiation visits, etc.

Make sure site staff are adequately trained in all project-related requirements and tasks

Support audit activities, as appropriate

Ensure site(s) maintains an acceptable inventory of clinical supplies and associated documentation

Rigorously maintain compliance with the company s business travel and expense policies

EDUCATION AND EXPERIENCE

Bachelor s Degree or higher in a healthcare or science related field. Consideration of a candidate with any alternate level of education will be case-dependent based on experience and positional need

Good Clinical Practices (GCP) certification from an accredited program is required

2+ years of relevant clinical research experience as a field-based CRA is required; medical device experience is preferred

KNOWLEDGE AND SKILLS

Fluent knowledge of spoken and written English language, including medical terminology

Superior written and verbal communication skills

Proficiency in presentation preparation and delivery

Technical savviness with an ability to understand the impact technology has on increasing effectiveness and performance

Previous experience with EDC, CTMS and eTMF systems required

Understanding of clinical study management processes and systems, including monitoring, investigational product handling, data management, etc.

Understanding of domestic and international clinical research guidelines, e.g. ICH GCP, FDA CFR, ISO, HIPAA

Ability to work in and promote team cohesiveness in a virtual / remote environment

Exhibit flexible organizational change approaches with a growth mindset

Demonstrated ability to prioritize multiple tasks with challenging timelines and results

Ability to master understanding of the disease state and product(s) under investigation