Clinical Trial Associate

  • location: Sunnyvale, CA
  • type: Contract
  • salary: $68 - $79.50 per hour
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job description

Clinical Trial Associate

job summary:
Grow your career inside this leading Pharma company with the feel of a start up. This position will allow you to be very hands on and have you input incorporated in company processes.

General Position Summary/Purpose:

Under minimal supervision, the CPA II expands clinical trial and vendor management experience in the planning, designing, implementation and execution of clinical trial protocols. Works closely with sites and vendors to ensure compliance with overall clinical objectives and protocol. Effectively uses an established understanding of the disease, molecule and indication. Maintains high level of professionalism with communications both within internally and with external stakeholders.

 
location: Sunnyvale, California
job type: Contract
salary: $68.00 - 79.50 per hour
work hours: 8 to 4
education: High School
 
responsibilities:
Key Accountabilities/Core Job Responsibilities:

- Demonstrates knowledge of site management / monitoring practices - site evaluation, patient recruitment, site initiation, monitoring, investigator meetings, drug supply management, sample management, close out

- May assist with the review of monitoring trip reports and track resolution of all action

items

- Assists with data quality, CRF guideline development, ongoing clinical data review and discrepancy resolution across sites and study

- Proficient in performing manual, in-house review of CRF data for completeness and

accuracy and resolving data management and data query issues with study sites and

CRAs

- May assist in development of study tools and guidelines to be utilized by study sites

- Assists in the potential investigators and sites selection process

- Communicates with sites and vendors and maintains effective management of study

issues

- Reviews site's informed consents against the consent template for presence of GCP

requirements, protocol-specific information and for accuracy

- Basic skills in drafting informed consent templates, protocol and other documents,

applies knowledge of regulatory requirements/SOPs to assigned documents

- Proficient in coordination and review of regulatory documents from study sites to

ensure completeness, accuracy, and compliance at the site and in the Trial Master File

- Assists with addressing site and vendor issues and corrective action prevention plan

resolutions

- May present at Investigator/Study Coordinator meetings and represent Company in

the technology booth at scientific meetings, as necessary

- Ensures ongoing tracking of IND Safety Reports for assigned sites and works with CRAs

to support drug safety with resolution of open queries

- Assists manager/Lead CPA with the investigator contract, budget, and payment process

- Develops basic knowledge in vendor selection and management

- Prepare site payment tracking for management review

- Proactively partners with team members and other functional areas within

company such as Regulatory, QA, Legal, and Biometrics to lead joint efforts to

achieve project objectives or corporate goals

- In a team environment or when facilitating meetings, creates an inclusive, collaborative

environment that promotes co-creation, open dialogue, and decision making

- Ensures required corporate training on standard operating procedures, policies, and

work instructions are completed by the due date

- Contributes expertise to functional and cross-functional process improvement activities,

- Performs other work-related duties as assigned

 
qualifications:
Qualifications:

- Strong verbal and written communication skills with attention to detail and

organizational skills are required

- Demonstrates an understanding of what assigned tasks are on the critical path and uses this knowledge to guide time management and prioritization of activities

- Working knowledge of TMF/CTMS management with the ability to identify issues and

guide/provide resolution

- Understands GCP principals, their importance, and how they apply to operational

activities being managed or performed

- Understands country-specific variations in regulations and guidelines, and their impacts on trial execution

- Models integrity, fairness, and collaborative behavior in all interactions with individuals, teams, and functional areas

- Proactive about engaging the right stakeholders and leading joint efforts to achieve

project objectives or corporate goals

- Capable of leading delegated portions of documentation efforts to support regulatory

filings

- Proficiency in Computer skills including Microsoft Word, Excel, PowerPoint, and

organization tools

- SharePoint experience and filing systems experience is desirable

Education and Experience:

- BA/BS or equivalent degree in a scientific discipline, RN, or healthcare related field is preferred but is not required.

- 3+ years of CRA experience in industry setting, or four years of pharmaceutical or health care field experience

- 2+ year of site monitoring experience preferred

 
skills: MS-EXCEL, GCP (Good Clinical Practice), Trial Data Management, TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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