Senior Clinical Research Associate

ClinChoice

11h•Remote

About The Position

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, full-time position. Candidates must be located on the west coast and willing and able to travel to investigative sites as needed. This is a remote role; however candidate must be located on the west coast.

Requirements

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 eight 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

Nice To Haves

Gastrointestinal oncology and medical device clinical research experience, with an emphasis on therapeutic medical devices and HIFU therapy, is ideal.
In some cases, an equivalency, consisting of a combination of appropriate education, training and or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
GI oncology and medical device clinical research, with an emphasis on therapeutic medical devices and HIFU therapy is ideal.

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.