Senior Clinical Research Associate

Job Overview:

Covance is searching for the SCRA, sponsor dedicated for oncology studies, home based

Essential Job Duties:

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 Prepare accurate and timely trip reports Review progress of projects and initiate appropriate actions to achieve target objectives Report, write narratives and follow-up on serious adverse experiences Interact with internal work groups to evaluate needs, resources and timelines Act as contact for clinical trial supplies and other suppliers (vendors) 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 Perform other duties as assigned by management Education/Qualifications:

University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) Experience:In lieu of the above requirement, candidates with profound relevant clinical research experience in pharmaceutical or CRO industries may be considered Fluent in German and English verbal and written Monitoring experience in oncologic clinical trials preferred

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.