Senior Clinical Research Associate | BioNJ Talent Services

Senior Clinical Research Associate

Contact Information
Contact Name: 
Covance, Inc.
Organization Name: 
Covance, Inc.
Position Location: 
Munich, DE, USA
Job Description:

**Job Overview**

Covance is currently looking for a SCRA to be based in Germany as a **home based** employee. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

**Education / Qualifications**

Life science degree


+ 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 of document review

+ Monitor data for missing or implausible data

+ Ensure the resources of the Sponsor and Covance are spent wisely by performing 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 and 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 Quality Control Visits (CQC) when requested

+ Recruitment of potential investigators, preparation of EC submissions, notifications toregulatory authorities, translation of study-related documentation, organization of meetings andother 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

+ Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

+ Excellent understanding of Serious Adverse Event reporting

+ Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany.

+ Previous experience of leading/managing a CRA team

+ Experience of reviewing CRA trip reports

+ Fluency in speaking and writing both English and German

+ Oncology experience

+ Degree in life sciences OR equivalent experience in clinical monitoring

+ At least 3-4 years experience in clinical monitoring, oncology experience preferred

**Job Number** _2017-14581_

**Job Category** _Clinical Research Associate_

**Position Type** _Full-Time_

Additional Job or Internship Information
Position Type: 
Full time job
Job Reference: