Clinical or Senior Clinical Research Associate (In-House)

Location
San Diego, CA
Posted
Jun 29, 2018
Required Education
Bachelors Degree
Position Type
Full time

MEI Pharm, Inc., a is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. Our portfolio of drug candidates includes Pracinostat, an oral HDAC inhibitor that is being developed in combination with azacitidine for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Our clinical development pipeline also includes ME-401, a highly selective, oral PI3K delta inhibitor, voruciclib, an oral, selective CDK inhibitor, and ME-344, a novel mitochondrial inhibitor. MEI currently has an open position for a:

 

                        Clinical or Senior Clinical Research Associate (In-House)

Job Summary:

Bottom of Form

The Clinical Research Associate (CRA) or Senior CRA (SCRA) role is to assist the Senior/Manager, Clinical Operations during the conduct of one or more clinical studies. The CRA/SCRA ensures that clinical study timelines and budgets are met, data quality is high, and the studies are conducted in compliance with current applicable laws and regulations, corporate policies, and ICH and GCP guidelines. This position is based at MEI’s San Diego office with up to approximately 15% travel, as needed.

Responsibilities:

  • Assists the Senior/Manager Clinical Operations in overseeing clinical studies to ensure compliance with the study protocol, timeline and budget
  • Coordinates investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies
  • Coordinates contract vendors and Clinical Research Organizations activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs
  • Coordinates and maintains relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution
  • Assists with the design of clinical studies
  • Assists with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation
  • Reviews clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data
  • Participates in project team meetings and conference calls to review progress of ongoing clinical trials
  • May conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.

Requirements:

  • Minimum 3 years’ experience as a CRA in the biotechnology or pharmaceutical industry; experience in hematology and/or oncology preferred.
  • Completed (or is in the process of completing) a CRA Certification Course preferred
  • BS degree in a science or health-related science or equivalent preferred
  • Proficient knowledge of GCP and ICH and medical terminology
  • Ability to prioritize and multitask to ensure tasks are completed on or ahead of time
  • Strong interpersonal and written communication skills
  • Excellent team, organizational, and planning skills
  • Highly competent in Microsoft Office Suite including MS Word, Excel, PowerPoint
  • Only San Diego area candidates will be considered; there is no relocation benefit.
  • Submit resumes to hr@meipharma.com and to dmee@meipharma.com

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms
  • Regular communication (hearing/speaking)
  • Lifting of light-weight office supplies.
  • Routine office duties including computer keyboard use
  • Vision requirements include: close vision and ability to focus
  • Noise conditions range from quiet to moderate.