Job Details

ID #3441309
State Tennessee
City Memphis
Full-time
Salary USD TBD TBD
Source Covance
Showed 2020-02-21
Date 2020-02-22
Deadline 2020-04-22
Category Et cetera
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Clinical Research Associate - Respiratory

Tennessee, Memphis 00000 Memphis USA

Vacancy expired!

Job Overview:Clinical Research AssociateWhy settle for one thing when you can have everything. Covance gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks – working at Covance—one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.You will enjoy the best of both worlds—all the benefits that come along with Covance’s Energizing Purpose, Exceptional People and Extraordinary Potential combined with working exclusively with one sponsor using their systems and processes. This also comes with the benefit of bringing your strong therapeutic experience to a single protocol or sponsor portfolio. This allows your expertise to shine through as you also become engrained in the sponsor culture helping to bring more therapies out to patients.In this role, the selected candidate will be responsible for all aspects of site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; and liaise with vendors. Additionally, will be responsible for include all aspects of registry management and general on-site monitoring duties including ensuring that study staff have proper protocol materials and instructions; verification informed consent procedures and protocol requirements are adhered to per regulatory guidelines; ensuring integrity of data for the CRFs and other data collection tools with careful review; monitoring data for missing or implausible data. Also will ensure the resources of the Sponsor and Company 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 Company travel policy; performing CRF review, query generation and resolutions; Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management; update, track and maintain study-specific trial management tools/systems; track and follow-up on serious adverse events as assigned; and implement study-specific communication plan as assigned; and other duties as assigned. Education/Qualifications:University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.Experience:

A minimum of 6 months of Onsite Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.

Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements

Thorough knowledge of monitoring procedures

Basic understanding of the drug accountability process

Valid Driver's License

Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

Good planning, organization and problem-solving abilities

Ability to work with minimal supervision

Preferred: 1+ additional years of experience in a related field (medical, clinical, pharmaceutical laboratory, research, data analysis, data management or technical writing). 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.

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