Clinical Research Associate - Irvine, CA
About the position The Clinical Research Associate (CRA) assists the Clinical Affairs Team in the administration of clinical research studies. The CRA will respond to a variety of study account inquiries, issues and requests and act as a liaison between the lab and the study account. The CRA will monitor specimen TAT, set up new study accounts, manage current study accounts, requests, and track specimens, and ensure that all study specimens are adhering to the SOP. The CRA will work independently to monitor your study sites, including evaluation, initiation, routine and close out visits. The CRA will manage multiple aspects of subject’s welfare, including submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested. The CRA will monitor clinical study data for completeness and accuracy, perform data cleaning, reconciliation of data queries and generate data reports as needed. When required, the CRA will perform remote or on-site data mining in medical office EMR systems. Provide administrative support as needed to execute clinical study start up and close out duties. Provide assistance to study sites with respect to communication, study supplies, etc. Maintain close communication with the Director, Clinical Affairs, while taking initiative and working independently on assigned tasks. MDxHealth seeks talented people who are passionate about improving the diagnosis and treatment of cancer patients. MDxHealth is building world class healthcare company, providing significant career development and financial opportunities.
Responsibilities
- Respond to study account inquiries, issues and requests
- Act as a liaison between the lab and the study account
- Monitor specimen TAT
- Set up new study accounts
- Manage current study accounts
- Track specimens
- Ensure study specimens adhere to SOP
- Monitor study sites (evaluation, initiation, routine, close out visits)
- Manage subject welfare (protocol submission, consent documents for ethics/IRB approval)
- Assist in regulatory submissions
- Monitor clinical study data for completeness and accuracy
- Perform data cleaning
- Reconcile data queries
- Generate data reports
- Perform remote or on-site data mining in medical office EMR systems
- Provide administrative support for study start up and close out duties
- Assist study sites with communication, study supplies, etc.
- Maintain close communication with the Director, Clinical Affairs
- Work independently on assigned tasks Requirements
- Basic knowledge of biology, genomics, or molecular biology.
- Minimum of at least 1 year of study experience as a CRA, including at least 1 year of active independent field monitoring experience as a CRA— all types of visits.
- Experience with data mining, data review and data management.
- Strong problem-solving skills and ability to work independently.
- Self-motivated, detail-oriented, organized, and able to prioritize and manage multiple projects requirements simultaneously.
- Willingness to travel nationally 50% of the time or as needed.
Benefits
- competitive salary
- company paid medical, dental, vision and life insurance coverage
- 401(k) with company match
- generous employee discounts
- a casual, but driven work environment
- the ability to make a real difference as a key contributor to our growth Apply tot his job Apply To this Job
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