Clinical Research Associates - II & Senior (III) - Oncology – Remote Netherlands
Location: Amsterdam, Noord-Holland NL
Job Id: 2309
Position Title: Clinical Research Associate II / Senior Clinical Research Associate
At Precision for Medicine 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 positioning to make a difference, and stay because of the amazing people, reasonable travel and quality of life, carrying an average of one to two studies setting you up to be a protocol expert. Most meaningfully - your voice will be heard. You will have influence and impact when it matters most and support from direct line management.
We invite you to learn more about our growing organization serving our clients that are researching groundbreaking oncology, rare and other complex diseases. We are steadfast in ensuring our 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.
This is a remote opportunity focused on Oncology studies located from anywhere in the Netherlands preferrably with close or easy travel to the flemish parts of Belgium.
You are passionate about spending your professional time working on finding treatment options for patients and their families suffering from cancer.
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 have an outstanding eye for detail; identifying study risks and propose mitigation solutions.
How we will keep you busy and support your growth:
Monitoring and progressing of clinical studies at investigative sites ensuring that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. Coordinating 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.).
CRAs balance appropriately sized clinical trials, supporting Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. Interacting directly with clients, initiating payments, and participating in proposal activities, including development and client presentations.
- Europe: University degree life science/pharmacy/other health related discipline or equivalent experience in a scientific or healthcare discipline or licensed health care professional.
- North America: 4-year college degree or equivalent experience in a scientific or healthcare discipline.
- CRA experience in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies; 2+ years for CRA II and 3.5+ years for Sr. CRA, including significant site management experience or equivalent experience in clinical research.
- Oncology experience, preferably in early phases
- Excellent communication and organizational skills
- Evidence of a client focused approach
- Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
- Ability to travel overnight; up to 60% regional expected on average & based on regional requirements. International travel as needed.
- Fluency in English and for non-English speaking countries the local language of country where position based
- Monitoring in rare and complex therapeutic areas, EDC trials and EHR records
- Biopharma or meaningful therapeutic area
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country
- Monitoring study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines
- Resolving project related problems and prioritize workload to meet deadlines with oversight from management. Mentorship of junior CRAs in problem resolution
- CRA I level needs little to no practical experience however transferable skills from health care or related industries.
Precision for Medicine, 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 oncology, rare and other complex diseases.
Division: Precision For Medicine
Business Unit: Clinical Solutions
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Community / Marketing Title: Clinical Research Associates - II & Senior (III) - Oncology – Remote Netherlands
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
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. © 2020 Precision Medicine Group, LLC
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 QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Amsterdam, Noord-Holland NL