Note: The job is a remote job and is open to candidates in USA. ClinChoice is a global, full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, medical device, and consumer health companies. The company is seeking a contract Senior Clinical Research Associate to support an oncology medical device study by monitoring clinical trials, managing investigative sites, ensuring data quality and safety reporting, and supporting study start-up and closeout activities.
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
Skills
- Candidates must have 10+ years of CRA experience monitoring oncology and medical device clinical trials, as well as previous experience working for a CRO
- Candidates must be located on the west coast and willing and able to travel to investigative sites as needed
- University Degree in scientific, medical or paramedical disciplines
- Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; Nursing degree or relevant degree or background preferred
- Previous experience working for a CRO is required
- At least 10 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
- GI oncology and medical device clinical research with an emphasis on therapeutic medical devices and HIFU therapy, is ideal
Benefits
- Remote contract position
- Part-time with an estimate of 0.5 FTE
- Continuous training
- A fulfilling and rewarding career
Company Overview
Company H1B Sponsorship