Clinical Research Associate CRA - B

For further information please contact our Talent Specialist:

Divya (224)

Title: Clinical Research Associate (CRA) B

Location: Alameda CA

Duration: 6 Months with possible extension

Description:

• This position is NonExempt.
• Hours over 40 will be paid at Time and a Half.
• Member of the clinical team responsible for conducting Phase IIV single or multi center studies according to Federal Regulations and ICH guidelines.
• Responsible for assisting senior staff in planning study conduct designing case report forms (CRFs) Contract Research Organization (CRO) selection and management selection and training of investigator sites planning and running study meetings evaluation selection and training of new study investigators and writing and assembling submissions.
• Responsible for writing basic study protocols monitoring or overseeing monitoring of investigational sites to ensure protocol adherence assuring timely enrollment of patients and retrieval of CRFs from study sites processing CRFs including data cleanup and classification of data and completion of study summary.
• 35 Years Experience Level.

Position Summary

• The CRAII/Sr. CRA will assist in the clinical execution and management of all aspects of assigned clinical studies.
• This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards.
  

Essential Duties and Responsibilities
The incumbent may be asked to perform other functionrelated activities in addition to the below
mentioned responsibilities as reasonably required by business needs.
Conduct single or multicenter medical device clinical studies.
Perform study site visits (SQV SIV IMV COV) generate monitoring trip reports and track
resolution of action items.
Participate in study start up activities.
Responsible for shipping study devices and supplies to clinical sites and performing study device
accountability.
Manage clinical monitoring activities and overall site management ensuring compliance to the
Study Protocol Good Clinical Practices (GCPs) ICH guidelines Federal Regulations department
procedures and applicable regulatory requirements.
Responsible for assisting senior staff in planning study conduct designing case report forms
(CRFs) conducting User Acceptance Testing (UAT) Contract Research Organization (CRO)
selection and management selection and training of investigator sites planning and running
study meetings evaluation selection and training of new study investigators and writing and
assembling submissions.
Maintain and audit Trial Master File to ensure inspection readiness.
Perform review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Operations Manager as needed
Participate in crossfunctional clinical team(s) in the planning and execution of clinical trials.
Proactively and effectively communicate the status of clinical studies to management.
Ensures quality delivery of study deliverables within agreed budgets and timelines.
Participate in the interim and final reviews of study data in preparation of regulatory submissions.
Involved in the preparation of all applicable documents required for the conduct of the study (such
as Trial Master File (TMF) Clinical Protocols and Reports).
May interact with RA/QA in responding to audits and FDA inquiries.

Education and Experience
BS degree in life sciences or equivalent with a minimum 5 years of related experience or MS
degree in life sciences or equivalent with a minimum 3 years of experience or PhD with 2 years of
experience.
Must have 5 years of relevant experience in site monitoring clinical project management
clinical trial practices and regulations.
Experience in conducting medical device and/or invitro diagnostics studies. Pharmaceutical
background may also be considered.

Skills
Demonstrated excellence in teamwork shared mindset for success stellar interpersonal and
communication skills including building rapport with team members peers and management.
Solid understanding and demonstrated experience of the clinical trial process including study
design and conduct; clinical data management systems; clinical trial management systems; data
analysis; and data reporting and interpretation.
Must have a demonstrated ability to solve problems with innovative solutions along with strong
project management and organizational skills to deliver projects on time and on budget.
Able to manage numerous projects/conflicting priorities and to be flexible when priorities change.
Working knowledge of GCP Clinical and Regulatory Affairs.
Flexibility in daily activities.
Proficient with Microsoft Suite Excel and PowerPoint presentation

Travel Requirements

Must be able to travel 3050%

Notes

Exp having 35 years of CRA.

MS with 3 years and PhD with 2 years

Someone with monitoring experience and tracking action items.

Also participated in startup activities & collecting regulatory documents

Prepare the sites in training and SIP Case reports data management.

GCP ICH guidelines experience.

Expected to follow regulatory documents ZIVA TMF

Involved with report writing.

Skill Set

Excellent in teamwork and communication skills

Independent and solve problems.

GCP Clinical and regulatory activities

Monitoring exp is a MUST

About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.