Senior Clinical Research Associate

ClinChoice is a global, full-service CRO providing clinical research services to pharmaceutical, biotechnology, medical device and consumer health companies. We are currently seeking an experienced Senior Clinical Research Associate (Senior CRA) to join our in-house team. As a Senior CRA, you will manage 2–3 clinical trials and be responsible for site management activities, including study start-up, site monitoring, and closeout. You'll conduct both on-site and remote monitoring while supporting a variety of studies across a diverse client portfolio, from emerging biotech companies to large pharmaceutical organizations. This is a permanent, fully remote position. Candidates must be willing and able to travel to investigative sites as needed. Candidates must have experience monitoring oncology and other complex clinical trials, as well as previous experience working for a CRO. A strong understanding of GCP, ICH guidelines, and clinical trial operations is also required. Join our team: you can be part of making a difference in people’s lives and experience a fulfilling and rewarding career! This is a remote role, ideal locations are West Coast, New York and/or Florida. Main Job Tasks and Responsibilities: Keep professionally abreast of all scientific, regulatory and operational aspects relevant to the clinical projects assigned. Assist in the selection of sites, site evaluation visits, initiation visits and ensure follow-up by obtaining pre-study documentation to ensure good start-up of the investigation sites. May act as Feasibility Associate. Train site staff in all study procedures. Conduct periodic monitoring visits, including completion of monitoring visit report. Review at each visit the accuracy, legibility, completeness and quality of the Case Report Forms (CRF). Conduct source data verification and in-house review of clinical data and ensure timely resolution of data queries to guarantee reliable clinical data. Manage the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site. Cooperate with the site staff to ensure proper reporting from the site for safety issues (AEs, SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues. Conduct and report study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. Act as the main contact person for the site to ensure close follow up. Provide general support to the Clinical Research Division on quality control of clinical data. Address appropriate team members about any issues that can jeopardise the conduct of the clinical projects assigned in a timely manner. Report to the Head of department on all activities performed during the study and send all relevant documents according to the timelines and the requirements agreed for each single clinical trial. Develop training material and give training in collaboration with the Training & Qualification Management Unit. May assist with contract negotiation with sites on study budget after appropriate training. Assist with the preparation of the study, including CRF design/development, write CRF instructions and organise the study files and documents to ensure good start-up of the investigation sites. May support the submission process in the project including submission requirements, timelines, informed consent development, etc.. Guide and supervise Clinical Research Associate I (CRA I) to coach and train them on the job. Education, Experience and Skills: University Degree in scientific, medical or paramedical disciplines. Previous experience working for a CRO is required. At least eight (8) years of clinical research experience, including proven experience as a Clinical Research Associate (CRA) performing on-site monitoring activities. Experience with oncology, respiratory and complex trials is required. Strong knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements. Fluent in English and local language(s). Proficiency in Microsoft Office (e.g., Word, Excel, Outlook). Willingness to travel Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key words: Clinical Research Associate CRA Freelance Permanent CRO Contract Research Organization Outsourced Outsourcing Oncology Monitoring Early Phase Oncology Trials Senior CRA Oncology Clinical Trials

CAR T

Investigative Site Monitoring On-site Monitoring Remote Monitoring

1.0 FTE

70% Travel 1099 Independent Contractor GCP (Good Clinical Practice) ICH Guidelines FDA Regulations Regulatory Compliance Clinical Trial Operations Source Data Verification (SDV) Case Report Forms (CRFs) Data Query Resolution Safety Reporting (AE, SAE, SUSAR) Investigational Product (IP) Management Site Initiation Visits (SIV) Site Selection Visits (SSV) Close-Out Visits (COV) Feasibility Assessment Site Management Study Start-Up Clinical Data Quality Control Monitoring Visit Reports Investigator Study File (ISF) Trial Master File (TMF) Clinical Study Documentation Site Training Study Budget Negotiation Informed Consent Development Submission Support 8+ Years CRA Experience Advanced Oncology Experience Phase I Oncology Monitoring Early-Phase Oncology Trials CRO Experience U.S.-Based CRA #LI-VH #LI-Remote #Senior Clinical Research Associate # Permanent #J-18808-Ljbffr Doist