Associate Project Manger/ Project Manager- Hybrid

Job Type Full-time Description

EDUCATION & EXPERIENCE:

Any combination equivalent to the experience and education that are required by federal, State, and Local guidelines. The minimum requirements for experience and education are:

• Experience: Candidate should have at least 7 - 8 years of clinical research experience with at least 3 -4 years of monitoring experience for Oncology studies (Candidate with Oncology with ophthalmology experience prioritized)   
• At least 1-2 of Project Management experience 
• Life sciences degree or equivalent
• Minimal knowledge of clinical research process, clinical trials and medical terminology
• Demonstrated proficiency in Microsoft Office (i.e. Word, Excel and Outlook)
• Good Communication skills and able to drive the call with Group of Scientific professionals
• Willing to support and remain available to support different time zones (EST, PST, IST)
• Ready to travel ~ 30% throughout North America
• Office based role in Bakersfield preferable  - Hybrid model is fine (Once in a quarter candidate needs to spend at-least one week time in the office) 

Responsibilities:

• Maintaining identification and development of robust Site/Investigator Database for different indications
• Performing Project specific site level feasibility assessment
• Short listing the sites from the in house database where the feasibility assessment was performed
• Collection of study documents (IU/PSP/CV/FDA 1572 etc.) from site for regulatory submission
• Coordinate or Collection documents from sites for IRB submission
• Preparing and submission of IRB related documents to Site for EC submission in consultation with CRA/PM.
• Tracking of IRB submission and approval
• Maintaining Project specific Clinical trial supply to the site like ISF, PF and PK kits, Central Lab kits etc.
• Finalizing the material, Coordinate with vendors and to send the Cards/keychain/posters for exclusion/ inclusion to sites
• Assisting PM for getting the Site agreements executed
• Maintaining site files, trial master files, trial related trackers, draft communications etc.
• Ensuring the study startup related activity tracking and reporting to Line Manager
• Registering the applicable clinical study with clinicaltrials.gov and update periodically during the study period
• Perform activities according to the protocol and SOP for in house (CPU) studies.
• Supervise the Volunteers/Subjects according to the SOP at the Clinical Pharmacology Unit (CPU).
• Monitoring of temperature/humidity of work are and equipment as per the SOP.
• Meticulously maintain equipment calibration records and status by tracking the calibration due dates.
• Reviewing the TMF periodically for the completeness and follow up with CRA and/or PM for any open action items.
• Resolving the QA audit findings in consultation with CRA/PM.
• Assisting PM for the weekly/monthly project status report
• Ensure compliance with the Quality Standard requirements of quality management system and relevant documentation.
• Ensure compliance as per ICH - GCP and USFDA regulations.
• Other duties as assigned by Line Manager, CRA, PM, Head-PM and DO

Others:

• Job Location: Hybrid
• Travel as needed.

Comprehensive Blood & Cancer Center is in full compliance with any and all Federal/State mandates. CBCC is committed to compliance with all applicable laws providing equal employment opportunities.

AT-WILL EMPLOYMENT

All employment with CBCC is At-Will Employment. While we strive to provide fulltime employment to all of our employees who so desire, we make no guarantees, expressed or implied, to provide any guaranteed number of hours of employment in a given week. Changing conditions in the healthcare field make it impossible to predict the demand for our services and as a result all of our offers of employment are offers of At-Will employment.

Salary Description $80,000-$130,000 DOE