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Sr. Clinical Research Associate - ONC FSP

Covance 10/4/2018 11:57:46 AM
JOB ID: 24408 Category: Clinical Research Associate
San Francisco, California

   

 

Job Overview

Clinical Research Associate

Are you ready to redefine what's possible, and discover your extraordinary potential at Covance? A career here provides the unique chance to create a lasting impact and difference in our patient's lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative work place, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.

Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.

Essential Job Duties:

* Working within an FSP model, embedded within a client
* Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
* Responsible for all aspects of site management as prescribed in the project plans
* General On-Site Monitoring Responsibilities:
* Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
* Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
* Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
Monitor data for missing or implausible data
* Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy

* Travel, including air travel, may be required and is an essential function of the job.
* Prepare accurate and timely trip reports
* Manage small projects under direction of a Project Manager/Director as assigned
* Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned
* Review progress of projects and initiate appropriate actions to achieve target objectives
* Organize and make presentations at Investigator Meetings
* Participate in the development of protocols and Case Report Forms as assigned
* Participate in writing clinical trial reports as assigned
* Interact with internal work groups to evaluate needs, resources and timelines
* Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
* Responsible for all aspects of registry management as prescribed in the project plans
* Undertake feasibility work when requested
* Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested
* Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
* Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
* Assist with training, mentoring and development of new employees, e.g. co-monitoring
* Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management-
Education/Qualifications

Minimum Required:
-
External Candidates

* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),

AND

* a minimum of 4 years of Clinical Monitoring Experience .

* In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring Experience will be considered.

Internal Candidates

* Internal candidates with a minimum of 4 years of clinical monitoring Experience .
* Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
* Thorough understanding of the drug development process
* Fluent in local office language and in English, both written and verbal

Preferred:

* Thorough knowledge of Covance SOPs regarding site monitoring

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Experience

Minimum Required:

* External Candidates
* University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure),

AND

* a minimum of 4 years of Clinical Monitoring Experience .

* In lieu of the above education requirement, external candidates with a minimum of 6 years recent clinical monitoring Experience will be considered.

* Internal Candidates
* Internal candidates with a minimum of 4 years of clinical monitoring Experience .

* Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
* Advanced site monitoring skills
* Advanced study site management skills
* Advanced registry administration skills
* Ability to work with minimal supervision
* Good planning and organization skills
* Good computer skills with good working knowledge of a range of computer packages
* Advanced verbal and written communication skills
* Ability to train and supervise junior staff
* Ability to resolve project-related problems and prioritizes workload for self and team
* Ability to work within a project team
* Works efficiently and effectively in a matrix environment
* Valid Driver's License-
Preferred:

* One (1) or more year's additional Experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
* Local project coordination and/or project management


Position Type: Full-Time

Location: San Francisco, CA - California



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).