Clinical Trial Associates & Senior Clinical Trial Associates - CRO - Oncology
Location: Edinburgh, Scotland GB
Job Id: 1931
Position Title: Clinical Trial Associate & Senior Clinical Trial Associate
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO. Our uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
We offer opportunities for both CTAs and Senior CTAs who will be providing administrative support to project teams in clinical operations. You will support several clinical programs and participate on a number of project teams as a valued member of the Project Team contributing towards efficient management of trials. Senior level CTAs serve as Subject Matter Experts with a focus on mentoring and training.
- 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 know how to mitigate them.
- You are adept at handling conflict by using tried and true resolution strategies.
- You are ambitious, collaborative, agile, and a standout colleague.
How we will keep you busy and support your growth:
- Handling inventory, tracking, and shipping for clinical trials supplies (consisting of CRFs, study drug where applicable, and other supplies)
- Assisting with preparation and shipment of Operating Manuals
- Developing and maintaining the study specific investigator database for use with correspondence and mail merges
- Updating and maintaining study tracking including a master team contact list
- Preparing and distributing initial site start up packages and liaises with the sites to obtain required regulatory documents
- Assisting team leaders in the production of study reports and updates
- Serving as an office based point of contact for all sites during the course of the study as well as provides phone coverage for travelling team members
- Preparing investigator budget payments and distributing to sites
- Serving as administrator of the Trial Master File with direction from Project Management, including the preparation, maintenance, and archiving of the TMF
- Identifying and processing Serious Adverse Events according to the procedures defined by the study team
- Assisting with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management support
- UK GCSE or equivalent local level qualifications
- Experience in a Clinical Trial Administration role or related discipline; CTAs will have 1-3 years and Sr. CTAs will have 3-5 years of experience
- Basic computer skills, including word processing
- Working knowledge of ICH-GCP, SOPs, and regulatory guidance including a good knowledge of the regulatory and safety processes
- Limited travel may be required for this position
- CRO experience
About Precision for Medicine, Oncology & Rare Disease
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping our clients 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.
Division: Precision For Medicine
Business Unit: Oncology & Rare Disease
Office Based: Edinburgh - 63A George Street, 3rd Floor, Edinburgh, UK, EH2 2JG
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available: No
Country: United Kingdom
Community / Marketing Title: Clinical Trial Associates & Senior Clinical Trial Associates - CRO - Oncology
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. © 2018 Precision Medicine Group, LLC
Location_formattedLocationLong: Edinburgh, Scotland GB