Senior Clinical Research Associate

Location
Emeryville, California (US)
Posted
Nov 15, 2018
Ref
CRA-SFCA
Required Education
Bachelors Degree
Position Type
Full time

Senior Clinical Research Associate- Updated

The Senior Clinical Research Associate (Sr. CRA) will be responsible for ensuring high quality execution of single and multi-site clinical studies according to the protocols, while adhering to GCP, and to Adamas Pharmaceutical Inc. SOPs within reasonable limits of time and budget reports to the Dir. Clinical Operations.

Responsibilities:

  • Identify and qualify potential investigational sites

  • Coordinate and perform comprehensive site management

  • Conduct pre-study selection, site initiation, interim and close out monitoring visits

  • Assist Trial Team in drafting study related plans

  • Submit comprehensive visit reports and status reports in a timely manner

  • Resolve and/or escalate logistical, data and audit issues

  • Adhere to the study timelines and budget, in line with managers’ expectations

  • Collect and review trial essential documents and prepare documents for ethics committee

    and/or regulatory submissions and supervise filing or assist in filing of essential documents

  • Prepare materials for presentation at investigator meetings or site initiations and other

    project-related forums

    Qualifications:

  • Five to seven years of clinical research experience

  • Life Science degree or equivalent or Registered Nurse

  • Fluent in the English language and local languages as required for the performance of source

    data verification and communications; strong written and verbal communication in English

  • Knowledge of ICH-GCP and applicable local and international regulatory guidelines

    (preferred)

  • Demonstrated knowledge of clinical monitoring, follow company SOPs and applicable

    regulatory requirements

  • Attention to detail and a methodical and systematic approach to work

  • Strong interpersonal skills and an ability to communicate at all levels

  • A proven ability to organize, take initiative and follow-up independently

  • Knowledge of computer software: Microsoft Word, Excel, PowerPoint, Project, Visio,

    Outlook; SharePoint (preferred)

  • Ability to travel

  • Successful experience in fast-paced entrepreneurial environment

  • Fit with Adamas culture and values

    Adamas is an Equal Opportunity Employer

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.