Senior Clinical Research Associate (East Coast based)

ERGOMED; Philadelphia (Philadelphia County); Hybride; USD 70 000 - 110 000; Plein temps

Résumé du poste

Ergomed Group is seeking a Clinical Research Associate to perform on-site or remote monitoring activities across Pre-Study, Initiation, Interim and Close-Out visits, ensuring sites have the qualifications and resources to conduct studies in oncology and rare diseases.

You will collaborate with investigators and staff, train site teams, and, when needed, assist with regulatory submissions. A Life Sciences degree, fluency in English, and the ability to travel nationally are required.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease
• Full working proficiency in English
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel nationally

Responsabilités

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
• Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period.
• Trains investigational site staff as necessary
• When applicable, supports preparation of regulatory and / or EC submissions
• Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance

Connaissances

On-site monitoring

Planning

Multitasking

Team collaboration

Travel nationally

Formation

Life Sciences degree

Description du poste

Company Description

Medicine moves forward here. So will you.

Clinical trials, safety studies, and audits make safe and innovative pharmaceutical-led care possible. As part of Ergomed Group, you help patients benefit so they experience more of life’s meaningful moments. Biopharmaceutical companies are our clients. Patients are our purpose.

Ergomed Group brings together Ergomed CRO, PrimeVigilance, Prudentia, and ADAMAS Consulting to help biopharmaceutical companies develop, deliver and safeguard therapies in oncology, rare disease and other complex areas of medicine. Across the Group, our teams turn the signals that clinical trials, safety systems and quality data generate into insight that helps bring safer treatments to patients around the world.

The science and analysis that guides our work is demanding. And this is where we excel. What defines us, though, is how we work together. Across countries, cultures and time zones, we bring kindness, curiosity and a shared sense of purpose to work that genuinely matters. Ideas are welcome here. Growth is expected. And every person has room to make a real difference to patients' lives.

Whether you are early in your career or bringing decades of experience, we want you to feel valued for what you do and for who you are. If that sounds like the place you have been looking for, we would love to hear from you.

Job Description

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities to ensure that facilities and staff at the investigational site continue to be adequate for the conduct of the study
• Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff to conduct the clinical study throughout the study period.
• Trains investigational site staff as necessary
• When applicable, supports preparation of regulatory and / or EC submissions
• Participates in mentoring/training of new staff as well as performing co-monitoring visits, to assess junior staff performance.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Extensive on-site monitoring experience in phase 2/3 trials, ideally with experience of complex trials in oncology or rare disease
• Full working proficiency in English
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel nationally

Additional Information

When you join Ergomed Group, you make a difference by helping to bring safe and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.

We are diverse in many ways, yet our values unite us. Our values are how we work, not words on a wall. If they sound like you, you will feel at home here.

• Quality: we hold ourselves to the standard patients deserve.
• Integrity and trust: we do the right thing, especially when it is hard.
• Drive and passion: we care about the outcome, because someone is waiting on it.
• Agility and responsiveness: we move quickly, because patients cannot wait.
• Belonging: everyone is welcome, and every voice counts.
• Collaborative partnerships: we go further by going together.

We look forward to welcoming your application.