Clinical Research Associate 2

Covance Inc. Great service, exceptional growth! As a billion dollar company with widespread global reach, Covance's ability to offer integrated drug development services is unsurpassed. Covance has achieved impressive growth by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance is committed to that mission - to cultivate the varied skills, cultures, ideas and experiences of every employee around the globe. There is no better time to join us!


I. Job Summary:

Assures the implementation of project plans as assigned.

Site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.

Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.

Registry management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP.

Act in the project role of as Local Project Coordinator or Lead CRA as assigned.

A. Duties and Responsibilities:

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.

General On-Site Monitoring Responsibilities
(a) Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
(b) Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
(c) 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.
(d) 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.
(e) Prepare accurate and timely trip reports.

Responsible for all aspects of site management as prescribed in the project plans.

Responsible for all aspects of registry management as prescribed in the project plans.

Undertake feasibility work 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.

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.

Complete 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.

Co-ordinate 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.

Qualifications
II. Education/Qualifications:
Required:

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).
In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered

Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.

Thorough knowledge of monitoring procedures.

Basic understanding of the clinical trial process.
Preferred:

Thorough knowledge of Covance S.O.P.s for site monitoring.

III. Experience:
Required:

Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
In lieu of the above requirements, candidates with three (3) years of site management and/or registry administration experience will be considered.

Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.

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.

Good communication and interpersonal skills.

Good analytical and negotiation skills.

Computer competency.

Fluent in local office language and in English, both written and verbal.

Works efficiently and effectively in a matrix environment
Preferred:

One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.



At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. Covance is well-positioned for continued growth! Click here to learn more: about