Clinical Research Associate II

Precision for Medicine; United States; Remote; USD 48,000 - 78,000; Full time

Job summary

Precision for Medicine in Germany is recruiting Clinical Research Associates (various seniority levels) to join our oncology and rare disease portfolio. You will monitor studies at investigative sites, ensure adherence to protocol, SOPs, ICH-GCP, and regulatory standards while coordinating site initiation, regulatory submissions, and pre-study visits.

Ideal candidates hold a science/healthcare degree with at least one year as a CRA, are fluent in English and German, and are prepared for domestic

Qualifications

• Graduate or postgraduate degree in a scientific or healthcare discipline.
• At least one year CRA experience in CRO or pharmaceutical/biotech industry or equivalent.

Responsibilities

• Monitor progress of clinical studies at investigative sites and ensure conduct/recording/reporting per protocol, SOPs, ICH-GCP and applicable regulations.
• Coordinate activities to set up and monitor a study (identify investigators; assist with regulatory submissions; pre-study and initiation visits).

Skills

English (fluent)

German (fluent)

Communication skills

Organizational skills

Travel willingness

Education

Science/Healthcare degree

1+ year CRA experience

Job description

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 Associates (different seniority levels) to join our team in Germany.

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; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).

Qualifications:

Minimum Required:

• Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline
• At least one year as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research.

Other Required:

• Excellent communication and organizational skills are essential. A team player.
• Evidence of a client focused approach.
• 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 German
• Experience in oncology, CAR-T or FIH studies (phase III)

Preferred:

• Study start up activities experience
• Medical device experience

  #LI-EK1 #LI-Remote

  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.

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  Precision Medicine Group 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.

  If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [e-mail].