Clinical Research Associate II/ Senior Clinical Research Associate

Precision Medicine Group (New York, United States); United States; A distancia; USD 56.000 - 83.000; Jornada completa

Descripción de la vacante

Precision for Medicine is seeking a Clinical Research Associate II / Senior CRA. This fully home-based role is in the United Kingdom or Northern Ireland, with travel up to 50-60% to investigative sites.

You will monitor studies to ensure adherence to protocol, ICH-GCP, and regulatory standards, and support site setup and regulatory submissions. Ideal candidates have a 4-year degree, 1+ years CRA experience in CRO/pharma, oncology experience, and English fluency.

Formación

• 4-year college degree or equivalent experience.
• 1+ years CRA experience within the CRO or pharmaceutical industry.
• Oncology experience essential.
• Phase I experience desirable, although not essential.
• First-In-Human (FIH) desirable, although not essential.
• Availability for domestic travel including overnight stays; international travel may be required for some senior level positions.
• Fluency in English.

Responsabilidades

• Monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Conocimientos

English fluency

Educación

4-year college degree or equivalent experience

Descripción del empleo

Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will have a lower than average number of protocols, setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management.

We are hiring a Clinical Research Associate II/ Senior Clinical Research Associate, this position will be fully home based working in the UK or Northern Ireland.

About you:

• You are calm, thoughtful, and responsive when things don't go as planned.
• You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game.
• You find quick and creative ways of overcoming difficulties.
• You have an impeccable eye for detail.
• You identify potential study risks and propose solutions on how to mitigate them.
• You take responsibility in the quality and outcomes of your work.
• You are adept at handling conflict by using tried and true resolution strategies.

How we will keep you busy and support your growth:

You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Qualifications:

Minimum Required:

• 4-year college degree or equivalent experience

Other Required:

• Candidates should ideally have more than 1 years CRA experience within the CRO or pharmaceutical industry.
• Oncology experience essential
• Phase I experience desirable although not essential
• First-In-Human (FIH) desirable although not essential
• Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions)
• Fluency in English

Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.

Precision medicine is revolutionizing the attack on cancer-and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions- and optimize the oncology development pathway.

We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.

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the company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

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Candidates must be legally authorized to work in the country of employment without employer sponsorship.