Precision for Medicine, Oncology and Rare Disease 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. We are now recruiting Clinical Research Associate II/ Senior Clinical Research Associate to join our team in Romania. The selected individual will also be expected to support Regulatory and Site Start-Up activities.

CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies 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.

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; prepare and complete regulatory submissions, support site contracts negotiation, collect essential documents and achieve site activations, conducting pre-study and initiation visits, etc.).

Qualifications:

Minimum Required:

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline

Other Required:

• Min 2 years of experience as a CRA within the CRO or pharmaceutical industry
• Previous experience as an administrator or in house CRA
• 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 and for non-English speaking countries the local language of country where position based
• Site start-up activities experience

Preferred:

• Experience in oncology and pulmonary studies
• Experience in site contracts negotiation
• Experience in Site Start-Up activities including but not limited to Informed Consent Form country adaptation, compilation of packages and completion of regulatory submissions, IP Release process and site activation.

Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. 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.