marsbet basiskele escort big bass bonanza sugar rush oyna gates of olympus marsbahis adresi
Clinical Research Associate job at GForce Life Sciences Alameda County, CA, US - mintshub.com

Clinical Research Associate Job at GForce Life Sciences, Alameda County, CA

NnFncXJmeVRTZ2xmS2txNTZ0UGZNMVlzZmc9PQ==
  • GForce Life Sciences
  • Alameda County, CA

Job Description

Clinical Research Associate

6 month contract with possible extension

On-site in Alameda, CA with 50% travel required

Must be able to work on a W2

Position Summary

The CRA B 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.

Education and Experience

  • BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate education and experience required.
  • Must have 3+ years of relevant experience in site monitoring, clinical trial practices and regulations.
  • Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.
  • Must be able to travel 30-50%

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.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Conduct single or multi-center medical device clinical studies.
  • Perform study site visits (SQV, SIV, IMV, COV), ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements, generating monitoring trip reports, and track resolution of action items.
  • Participate in study start up activities.
  • Responsible for ensuring shipment of study devices and supplies to clinical sites and performing study device accountability.
  • Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), selection and training of investigator sites, planning and running study meetings, evaluation, selection, and training of new study investigators.
  • 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 cross-functional 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.

Job Tags

Contract work, Interim role, Flexible hours,

Similar Jobs

Ascension

RN Registered Nurse - Renal Diabetes Medsurg Job at Ascension

Details Sign On Bonus Up to $20,000 Department: Renal Dialysis Schedule: Full Time Night, (3) 12 hour shifts, 7 pm-7 am Hospital: Saint Thomas West Location: Nashville, TN Our Renal Dialysis unit is a 24 bed, fast paced Medical Surgical unit. We care...

Cutting Edge International

Executive Assistant to President/CEO Job at Cutting Edge International

 ...The Executive Assistant to the President/CEO will at all times maintain a spirit and standard of excellence in ministry and put the missions purposes ahead of personal agendas, while upholding the name of Jesus Christ. PERSONAL CHARACTERISTICS The Executive Assistant... 

MLB & Associates

Safety Manager Job at MLB & Associates

 ...Job Summary: The Safety Manager is responsible for maintaining the policies and procedures for safety compliance and DOT operational...  ...overall safety cultures of the assigned region. OSHA general industry compliance at all facilities. OSHA compliance for presence... 

Mountainland Technical College

Bookstore Associate Job at Mountainland Technical College

 ...Full job description Job Title: Bookstore Associate Location: Spanish Fork, UT Status: Part-time Hours: Monday Thursday 1:00 p.m. 6:30 p.m., Friday 1:00 p.m. 5:00 p.m. Pay / Hourly: $12.36 SUMMARY As the Bookstore Associate... 

Tesla Training Center

Student Admissions Representative Job at Tesla Training Center

 ...Company Description We suggest you enter details here. Role Description This is a part-time hybrid role for a Student Admissions Representative at Tesla Training Center in Chicago, IL. The representative will be responsible for communicating with prospective students... 

marsbet basiskele escort big bass bonanza sugar rush oyna gates of olympus marsbahis adresi