CRA/Sr. CRA - Clinical Development

Location
Hayward, California
Salary
TBD
Posted
Jun 22, 2018
Ref
CD - CRA
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

In this role, you will have the opportunity to work independently and collaboratively in an exciting young company.  

Overall Description: 

The Clinical Research Associate (CRA) will provide clinical study support for one or more clinical studies/programs, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as managing clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring, meeting milestones and deliverables, and internal/external communications. This is an in-house position and will report to the Director/Associate Director, Clinical Operations. 

Job Duties and Responsibilities: 

Responsibilities may include, but are not limited to:

  • Obtains and reviews all required essential documents necessary for study/site initiation
  • Maintains accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
  • Ensure studies are managed and executed in accordance with ICH GCP, regulations, the protocol and company SOPs
  • Supports and may lead the development and review of clinical study plans, presentations or study-related documents
  • Supports in the development and design of CRFs, including participating in the EDC and IWRS specification process and UAT
  • Assists with set-up of central labs and study vendors as required, including liaising with Project/Program Manager and CRO to ensure site training and timely initiation
  • Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Project/Program Manager, as needed
  • Manages clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
  • May perform accompanied site visits with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and study plans, as required
  • Reviews monitoring trip reports and track resolution of all action items
  • Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
  • Assists with providing oversight of CROs and vendors including managing cross-functional teams
  • Responsible for oversight and mentoring of junior team members
  • Collaborates with internal cross functional teams to ensure effective delivery of the assigned project milestones
  • Organizes and manages internal team meetings, investigator meetings, and other trial­ specific meetings, as requested
  • Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
  • May visit sites (in conjunction with CRO, if applicable) for oversight, site evaluation, initiation, monitoring, or close-out activities
  • Participate and respond to Quality Assurance and regulatory authority inspection audits
  • Recommends and implements innovative ideas to increase efficiency and quality of project/program management activities 

Qualifications:

  • Bachelor’s degree, preferably in a scientific field
  • Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent
  • Demonstrates core understanding of medical terminology and clinical trial activities

Skills/Abilities:

  • Thorough understanding of ICH GCP guidelines
  • Understanding of clinical trial processes from study start-up through study closure
  • Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
  • Self-motivated, assertive and able to function independently or as part of a team
  • Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
  • Proven problem solving and decision making skills
  • Ability and willingness to travel 10-20% (domestic and international)