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Clinical Research Associate (CRA) II

Vicarious Surgical
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A mid-level position in Clinical Affairs, under some supervision of the Manager of Clinical Affairs. This position assists in the planning, designing, and executing of high-quality clinical studies to ensure safety and effectiveness of Vicarious Surgical products. Works with confidential patient and company data and may interface with a variety of internal and external stakeholders. Depending upon Clinical requirements may be directly involved in the monitoring of trials. This position requires on-site presence twice a week, in Waltham, Ma. 

Responsibilities
  • Assists with the development and/or maintenance of Clinical Affairs infrastructure such as the drafting of or reviewing of SOP’s and Work Instructions.
  • Directly involved with the development, approval, and distribution of study-related documents including (but not limited to) Case Report Forms (CRF’s), study protocols, informed consents, study manuals, and other study tools under the supervision of the Manager of Clinical Affairs.
  • Independently performs study site qualification, initiation, periodic monitoring, and close out visits.
  • Assists with contract CRAs/CRO and general vendor oversight.
  • Acting as a company liaison, attends operating room procedures to support study protocols.
  • Works with clinical sites to resolve any site related issues quickly and effectively.
  • Works effectively across departments (Regulatory, Quality, R&D, Sales and Marketing) to facilitate program goals.
  • Prepares Clinical Evaluation Reports (CER) under the direction of the Manager of Clinical Affairs.
  • Assists with on-going literature searches.
  • Provides on-call help for sites, as well as on-going site training.
  • Gathers documents and information for clinical investigator and laboratory selection.
  • Manages clinical device accountability, inventory, distribution, and returns.
  • Prepares and participates in presentation of protocols and other study conduct requirements at investigational sites.
  • Monitors subject screening and enrollment at clinical sites.
  • Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Trial Master File.
  • Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.
  • Tracks and reports progress of studies including patient enrollment/screening, data collection, adverse event documentation, and FAQ’s.  
  • Assists in query writing and resolution process, as required. Identifies and gathers missing or incomplete data from the investigational sites.
  • Assists in the collection and maintenance of study data and collateral materials for reports to senior management and regulatory authorities. o This may include reviewing clinical documents and reports, reviewing data listings, participating in the completion of medical writing assignments and performing quality control reviews.
  • Assists the Manager of Clinical Affairs with the development and implementation of corrective actions for addressing noncompliance issues at individual sites and across study. 
  • Assists the Manager of Clinical Affairs in identifying sites to be audited by either Corporate Compliance or Clinical staff. Assists with study site audits.
  • Taking an active role in the project team by providing feedback and suggestions for successful completion of the project.

Competencies
  • Knowledge and understanding of the job requirements.
  • Someone who is energetic, dynamic, hands-on, and self-motivated.
  • Ability to establish credibility, trust, and strong working relationships.
  • Excellent interpersonal, communication, and organizational skills.
  • Knowledge of data collection and analysis. 
  • Working knowledge of Good Clinical Practice (GCP).
  • Ability to manage multiple tasks simultaneously. 
  • Good verbal and written communication skills. 
  • Detail oriented and good problem-solving ability.  
  • Ability to work on teams and with multiple projects. 
  • Working knowledge of medical terminology required. 
  • Excellent computer skills (experience with spreadsheets and word processing programs).
  • Must have a working knowledge of GCPs, medical device regulations (21CFR, MDD/MDR), and other global regulations, standards, and guidance.

Required Education and Experience
  • Bachelor’s degree required. Degree in science/health related preferred.
  • 2-3 years experience as a Clinical Research Associate
  • Medical device experience required, robotic experience preferred
  • 1 year of onsite clinical monitoring experience required.
  • Project management experience preferred.
  • Clinical research certification from ACRP or SOCRA preferred.
  • Ability to travel up to 40%.