In-House Clinical Research Associate I

Worldwide Clinical Trials; United States; À distance; USD 85 000 - 120 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking an Inhouse Clinical Research Associate to support study delivery and compliance with GCP and regulatory requirements. You will liaise with trial managers, sites, and cross‑functional teams to drive quality study execution and timely milestones.

The role emphasizes site management, documentation control, data quality, and proactive operational support across global sites, with a remote work setup for suitable candidates.

Qualifications

• Bachelor's degree in a medical, biological, physical, health, pharmacy or related science field preferred or equivalent education/experience.
• Clinical research experience in roles such as Study Coordinator or Clinical Trial Assistant.
• Knowledge of GCP, FDA/EU regulations, ICH Guidelines and SOPs.

Responsabilités

• Support site start‑up activities, including feasibility questionnaire coordination and essential document management.
• Coordinate distribution and tracking of study materials to investigative sites and ensure documentation is maintained.
• Review site documentation for quality and TMF maintenance and reconciliation.
• Conduct remote monitoring activities and support pre‑study, initiation, interim and closeout visits.
• Maintain regular communication with investigative sites and provide operational support.
• Review electronic case report forms and study data for completeness and compliance.
• Assist sites with data management queries, vendor requests, recruitment activities, and eligibility tracking.
• Generate study reports, maintain trackers, and provide updates for effective oversight.
• Support site personnel changes, training documents, regulatory collection, and vendor access management.

Connaissances

Planning & organization

Communication skills

English proficiency

Clinical research knowledge

GCP knowledge

Regulatory knowledge (FDA/EU)

EDC/eCRF familiarity

Team collaboration

Formation

Four-year degree in science/related field

Outils

EDC

eCRF

IVRS

Description du poste

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands‑on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

Make an Impact as an Inhouse Clinical Research Associate at Worldwide

As an Inhouse Clinical Research Associate, you’ll play an important role in supporting the successful delivery of clinical research studies while helping ensure compliance with Good Clinical Practice (GCP), applicable regulations, and study requirements. Working closely with Clinical Trial Managers, field CRAs, sites, and cross‑functional project teams, you’ll contribute to high‑quality study execution that supports clinical research and patient‑focused outcomes.

In this role, you’ll serve as a key partner in site management activities, helping maintain study documentation, support monitoring activities, coordinate site communications, and assist with data quality and operational oversight. Your work will help keep studies on track, support investigative sites, and drive the timely achievement of critical project milestones.

Where You’ll Work

This is a REMOTE role open to candidates based in Australia. You will collaborate with global teams across multiple time zones.

Travel may be required as needed to support remote monitoring and study‑related site activities.

What You’ll Do

• Support site start‑up activities, including feasibility questionnaire coordination, confidentiality agreement collection, and essential document management.
• Coordinate the distribution and tracking of study materials to investigative sites and ensure accurate documentation is maintained.
• Review site documentation for quality and completeness and support Trial Master File (TMF) maintenance and reconciliation activities.
• Conduct remote monitoring activities and support pre‑study, initiation, interim, and closeout visits under the guidance of Clinical Trial Managers and field CRAs.
• Maintain regular communication with investigative sites, providing operational support and helping resolve study‑related questions and issues.
• Review electronic case report forms and study data for completeness, consistency, and compliance with study requirements.
• Assist sites with data management queries, vendor‑related requests, study recruitment activities, and subject eligibility tracking.
• Generate study reports, maintain study trackers, and provide operational updates that support effective project oversight and decision‑making.
• Support site personnel changes, training documentation, regulatory document collection, and vendor access management.

What You’ll Bring

• A four‑year degree with a concentration in medical, biological, physical, health, pharmacy, or another related science field preferred; alternatively, equivalent education, training, and relevant clinical research experience.
• Clinical research experience in roles such as Study Coordinator, Clinical Trial Assistant, or other relevant research positions.
• Understanding of clinical research principles, processes, and Good Clinical Practice (GCP) requirements.
• Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures.
• Familiarity with electronic data capture (EDC), eCRF, IVRS, and other clinical research systems.
• Strong planning, organization, and time management skills with the ability to manage multiple priorities effectively.
• Excellent communication and interpersonal skills with the ability to collaborate across sites and cross‑functional teams.
• Proficiency in spoken and written English.

We love knowing that someone is going to have a better life because of the work we do.

To view our other roles, check out our careers page at Discover a world of difference at Worldwide!For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .