Site Start Up Lead - Remote

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 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. As a smaller CRO, 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 cancer & rare disease therapies. 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.
About You

• You are passionate about spending your professional time working on finding new treatment options for patients and their families suffering from cancer or rare diseases
• 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 impeccable eye for detail; identifying potential study risks and propose mitigation solutions.
• How we will keep you busy and support your growth:
• You will monitor and be responsible for 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.).

CRAs handle appropriately sized clinical trials, and support Project Managers with trials that are larger in scope. You will also have the opportunity to train and mentor junior staff members. You will interact directly with clients, initiate payments, and participate in proposal activities, including development and client presentations.
Minimum Required
Qualifications:

• 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.
  

Other Required

• Excellent communication and organizational skills am essential. An excellent teammate
• 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
• Select opportunities require Oncology experience preferably in early phases
  

Preferred

• Graduate, postgraduate degree
• Monitoring in rare and complex therapeutic areas, monitoring 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
• 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 rare diseases and oncology.
• CRA I level needs little to no practical experience however transferable skills from health care or related industries a plus

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 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.