Sr. CRA - Contract (Advanced Clinical)

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Posted: June 3, 2016

Job ID: 154

Job Summary

Term: Contract
Job Roles: Clinical Trial Monitoring
Therapeutic Experience: Oncology
Required Education: BS/BA in Life Science or related discipline, nursing background desirable
Required Experience: 4+ years
Compensation: 1099 $85/HR (door-to-door)

Job Description

Advanced Clinical is a global, clinical outsourcing organization built around delivering a truly better clinical trial experience. We have a great job opportunity for a Sr CRA’s to support one of our pharmaceutical clients:

Several needs coming up so will keep you posted on the additional details that will start coming in soon. Please let me know if you are interested and available in the coming weeks. (or if you know of someone else that would be interested/available.)
1099 $85/HR (door-to-door)
Interview process to take place in the next few weeks or June and to start in July.

Phases are Pivotal Ph 2, Pivotal Ph 1, Pivotal Ph 2
Contracts written for 1 year with probability of extension.
Across different, complicated oncology studies - liquid tumors – ALL or NHL or Gene Therapy Trials – 8 + yrs of exp.

Sites to start:
Upstate NY
St Louis

Job Summary
The Senior Clinical Research Associate role will support clinical trial management, site management, and data review and cleaning. Responsibilities include implementing trial set-up, execution, oversight and reporting for clinical studies while ensuring the trials are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.

The key deliverable for this role is to ensure timely, quality conduct of clinical studies according to protocols, Good Clinical Practice, Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials.

Primary Responsibilities
The Senior CRA, reporting to the Associate Director, Clinical Operations and under the direction of the Clinical Study Manger, works closely with his/her cross functional team, to achieve study objectives and corporate goals. Primary responsibilities may include:
Manage defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
Develop strong working relationships and maintain effective communication within the Clinical Operations Group, as well as other functional departments within the company.
Act as a clinical trial lead to solicit contract research organization (CRO) RFPs, assist in identification of optimal CROs, and manage CROs or other study vendors.
Work closely with study site staff and field-based site CRAs.
Provide or assist with training for internal and field-based external CRAs, CRO team members, and investigative site staff.
Provide timely, quality study metrics to study teams using a variety of tracking tools (tables, databases, spreadsheets and files).
Conduct pre-study, study initiation, interim monitoring, and close out visits and complete associated monitoring visit reports as specified in department SOPs and study specific monitoring plans.
Review monitoring reports and monitoring visit letters from other CRAs.
Assist clinical study sites with study startup activities, including IRB and IBC submissions and ensure collection and review of required essential study documents and reports.
Develop or assist in preparation of supportive study supplies and documents (e.g., lab kits, lab manuals, imaging manuals, site study tools and worksheets, product administration guide, non-clinical supply materials, IXRS, etc.).
Work proactively with the data management team to design and develop paper or eCRFs and assist with writing CRF completion and monitoring guidelines.
Review completed eCRFs or data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining as needed.
Monitor supply of investigational and comparator drug supply throughout the trial.
Assist with product accountability at site and take appropriate action to resolve discrepancies.
Maintain high level of familiarity with clinical literature in area of study.
Perform on-going review of the TMF to ensure files are properly maintained and archived.
Attend meetings, take and distribute meeting minutes.

Required Qualifications
8+ years pharma/biopharma industry experience in complicated oncology drug development, hematology oncology or gene therapy trials; on-site monitoring experience, preferably at large cancer treatment centers.
Global trial and CRO management experience is preferred.
Previous experience with electronic data capture systems preferred.
Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
Demonstrated ability in positive relationship building, with strong verbal and written skills.
Strong interpersonal skills, ability to work within a team, and attention to detail.
Good analytical and assessment skills, judgement, and problem solving skills.
Ability to travel for site monitoring and/or co-monitoring activities, attend investigator meetings or vendor visits/audits, as required (up to 30%).
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
Education Requirements.

If interested, please email your resume/CV to and let him know when you have time to discuss the position over the phone.

Mohammad Ouranos| Clinical Recruiter
Advanced Clinical
570 Pacific Ave, San Francisco, CA 94133
M 949-836-3439