- Title: Clinical Research Associate
- Code: RCI-6400
- Location: Santa Clara California (CA) 95054
- Posted Date: 11/16/2020
- Duration: 9 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
IVD experience is critical
20-30% travel involved. This is a 100% remote position
Would be travelling during with in US as of now during Covid
Wont be travelling internationally during Covid But once situation is better would be travelling internationally
Important Updates from the manager
- Training on client products during start of project so would need to go to California
- Will be travelling across the country when needed
- Monitor data and go onsite when needed
- Travel is needed to clinical sites all across USA
- IVD experience is needed
- Open for remote candidates
- Candidate won’t be travelling internationally during COVID
- CRA will be travelling for business purposes
- Experience with IVD
- Open for candidate with 3- 5 yrs. of experience
MAIN PURPOSE OF ROLE
This field includes Main Responsibilities imported from Legacy System.
- Responsible for implementing and maintaining the effectiveness of the quality system.
- The clinical research associate (CRA) designs, implements, and monitors clinical studies of new and modified in vitro diagnostic products.
- Ensures that the clinical studies are designed to validate product performance claims and support the products’ intended use.
- Prepares clinical data reviews and data summaries.
- Participates in the preparation of regulatory submissions and international registration packages.
- In general, the CRA performs responsibilities and task under the direction of a SCRA or CPM.
- Implements and maintains the effectiveness of the Quality System.
- Complies with all policies, established procedures, and regulations related to clinical research.
- Actively participates as a member of the cross-functional project team.
- With direction performs the following: - Assesses data generated by R&D/Business Teams.
- Prepares design validation plans.
- Prepares documents for clinical studies.
- Identifies and qualifies clinical investigators and clinical sites.
- Proposes and negotiates budgets for clinical studies.
- Initiates payments to sites.
- Obtains and reviews all required essential documents necessary for study initiation.
- Reviews data, prepares and presents clinical data reviews and data summaries.
- Responds to audits and data queries.
- Prepares the clinical sections of regulatory submissions and international registration packages.
- Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study.
- Acquires a basic understanding of the principles of the assay and/or instrument and “hands-on” knowledge and skills in performing assigned assays or operating instruments.
- Arranges for and assists in standard Statistical Support with the collection and statistical analyses of clinical data.
- Monitors standard clinical studies ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare is protected, ensures data integrity through completeness, accuracy, and legibility.
- Prepares and reviews product labeling and promotional materials.
- Conducts standard pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports. Initiates standard clinical studies and provides for investigator and staff training.
- Maintains accurate and timely sponsor/site correspondence and communication.
- Prepares and presents project progress reports to keep management and team informed.
- Supports publication or presentation of clinical data in professional journals or meetings.
- Maintains professional, product, and market expertise via independent reading, networking, and training.
- Implements all policies, established procedures, and regulations into daily operations as appropriate.
- Develops professional, expertise via professional and educational opportunities.
- Assumes responsibility for attending training sessions, presentations, and continuing education sessions.
- Works with assistance to prepare publications, abstracts, or presentations for professional meetings.
- Contributes to goal setting.
- Takes responsibility for achieving results.
- Honors commitments.
- Accepts and completes all management-directed work assignments such as clinical assignments, travel, and other tasks.
- Demonstrates good basic writing skills. (I.e. clear, concise, effective, and well-organized) Demonstrates good presentation skills. (I.e. clear, concise, effective, and well-organized), Tries to understand changes in work tasks, situations, and environment as well as the logic or basis for change.
- Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
- Participates in professional activities in the US and/or Internationally.
- Minimum Bachelor's degree B.S in biological sciences or medical specialty preferred.
- Other: Clinical Laboratory certification (MT, ASCP or equivalent) or certification as a clinical research associate (CCRA) is desirable.
- Minimum of 3 years clinical related experience Preferred site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience.