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….
ClinChoice 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, 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.
- 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. GI oncology and medical device clinical research with an emphasis on therapeutic medical devices and HIFU therapy is ideal.
- 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
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
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, Medical Devices, therapeutic medical devices, gastrointestinal studies, Investigative Site Monitoring, On-site Monitoring, Remote Monitoring, 1.0 FTE, Travel, 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, Medical Devices, CRO Experience, U.S.-Based CRA
#LI-VH #LI-Remote #Senior Clinical Research Associate # 0.5 FTE- part time
