Research & Development Institute, Inc.
  • Los Angeles, CA, USA
  • Competitive
  • Salary
  • Full Time

Competitive


About RDI

Research & Development Institute (RDI) is growing to be one of the pre-eminent Contract Research Organization and Research Lab dedicated to the In Vitro Diagnostic Industry. Since its founding in 2008, RDI has contributed to bringing 110+ new assays to the market either through sample collection trials or validation and verification testing trials.

RDI's customers include the largest In Vitro Diagnostic manufacturers and boasts a national network of physicians & labs.

About this Position

Position can be filled as CRA or Sr. CRA depending on experience.

The senior clinical research associate (SCRA) 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. Participates in the preparation of regulatory submissions. The SCRA has established a high degree of competence in clinical research. The SCRA has obtained prior exposure to all aspects of a clinical study and functions at a proficient level of independence with a significant degree of autonomy in conducting clinical research.

ROLE RESPONSIBILITIES

Participates in assessing project requests generated by R&D/Business Teams prior to initiation of 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.

Clinical responsibilities include:

o   Prepares clinical protocol, clinical brochure, case report forms, informed consents, and other required documents for clinical studies.
o   Identifies and qualifies clinical investigators and clinical sites.
o   Proposes and negotiates budgets for clinical studies.
o   Initiates payments to sites.
o   Obtains and reviews all required essential documents necessary for study initiation.
o   Initiates clinical studies and provides for investigator and staff training.
o   Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility.
o   Conducts pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports.
       Maintains accurate and timely sponsor/site correspondence and communication.
       Prepares and presents project progress reports to keep management and team informed.
       Responds to audits and data queries representing a project or team.
       Prepares standard the clinical sections of regulatory submissions and international registration packages.
       Prepares and reviews product labeling and promotional materials.
       Coordinates preparation of responses to IRB's questions regarding the clinical study.
       Prepares publications, abstracts, or presentations for professional meetings with minimal assistance.

 

Responsibilities related to business growth:
       Identify and implement improvements to the standard operating procedures and business processes
       Functions independently in the field and interacts with all levels of medical and scientific professionals.
       Advise and train newly hired CRAs and direct others in the completion of tasks and projects.
       Maintains professional, product, and market expertise via independent reading, networking, and training.
       Assumes responsibility for attending training sessions, presentations, and continuing education sessions to expand professional expertise via professional and educational opportunities.
       Serves as a resource person for most technical questions or directs inquiries to appropriate references.
       Encourages collaborative behavior, delegates effectively, and empowers others to take action.
       Gives effective feedback.
       Acts with fairness.
       Accepts and completes all management-directed work assignments such as clinical assignments, travel, and other tasks.
       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.

 

ROLE ACCOUNTABILITY:

       Successful and timely completion of clinical studies directly impacts the ability to meet product market entry dates.
       Early identification of unsatisfactory results, operations, or specific problems allows immediate action to be taken by appropriate groups.
       Resolution of problems and timely data analysis is critical to meeting the scheduled goals of the project.
       Accountable for the project scope and scheduled completion date.
       Works under general management direction.

 

QUALIFICATIONS:

       Minimum Bachelor Degree required.
       B.S. in biological science or medical specialty preferred.
       Clinical Laboratory Certification MT(ASCP) or CRA (CCRA) desirable.
       Knowledge of regulations and standards affecting GCP,IVDs or Biologics required  
       Minimum of 5 years clinical related experience, of which at least 2 clinical research monitoring with strong site management and monitoring skills or minimum of 5 years laboratory experience with IVDs, reviewing data and data analysis and applicable automated diagnostics instruments (e.g., Cobas, Atellica, Centaur).

Research & Development Institute, Inc.
  • Apply Now

    with our quick 3 minute Application!

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    I agree to ApplicantPro's Applicant Information Use Policy.*
  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.
logo home about us ivd trials pharma trials physicians contact careers