Senior Clinical Research Associate West Coast

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

Clin Choice is a global, full-service CRO providing clinical research services to pharmaceutical, biotechnology, medical device and consumer health companies. We are seeking a Contract/Freelance Senior Clinical Research Associate (Senior CRA) to partner with one of our sponsors on an oncology medical device study. This is a remote contract position for an experienced CRA with a strong background in oncology and medical device clinical research.

Candidates must have 10+ years of CRA experience monitoring oncology and medical device clinical trials, as well as previous experience working for a CRO. Gastrointestinal oncology and medical device clinical research experience with an emphasis on therapeutic medical devices and HIFU therapy, is ideal.

It is part-time with an estimate of 0.5 FTE. Candidates must be located on the west coast and willing and able to travel to investigative sites as needed.

Join our team: you can be part of making a difference in people’s lives and experience a fulfilling and rewarding career!

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.

Education,

Experience and Skills:

• 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. In some cases, an equivalency,…