Clinical Research Associate II & III - Oncology
Location: Philadelphia, Pennsylvania US
Job Id: 2787
Position Title: Clinical Research Associate II / Senior Clinical Research Associate
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.
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.
- 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.).
Senior 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.
- Graduate, postgraduate, 4-year college degree or equivalent experience in a scientific or healthcare discipline.
- Experience as a CRA in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies (at least 2 years for a CRA II and 3.5 years or more for a Senior CRA/CRA III). Significant site management experience or equivalent experience in clinical research.
- Excellent communication and organizational skills are essential. A team player.
- 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% travel on average, based on regional requirements. International travel may be required.
- Oncology CRA experience required preferably in early phases.
- Experience monitoring in rare and complex therapeutic areas are preferred.
- Experience monitoring EDC trials and EHR records.
- Experience in bioharma or relevant therapeutic area.
- Relevant site start-up (feasibility, contract negotiations, submissions) experience for the particular country preferred.
- Ability to monitor study sites, with supervision, according to protocol monitoring guidelines, SOPs, GCP and ICH guidelines.
- Ability to resolves project related problems and prioritize workload to meet deadlines with oversight from management. Senior CRAs can assist junior CRAs in problem resolution.
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.
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: Yes
Country: United States
Community / Marketing Title: Clinical Research Associate II & III - Oncology
Country: United States
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: Philadelphia, Pennsylvania US