CRA II (Phase I/IIa)

78752 Job posted on: 4/25/2008 At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. There is no better time to join us! The Clinical Research Associate II (CRA II)conducts site monitoring responsibilities at our Clinical Research Units located in WI, IN, FL, TX, CA, ID, OR & HI, according to Covance Standard Operating Procedures, ICH guidelines and GCP, including Pre-study qualification, Initiation Meetings, Routine, Interim monitoring Visits and Close-out Visits. The Clinical Pharmacology unit has experience in Early Pharmacology Clinical Trials (Phase I and IIa). ESSENTIAL JOB DUTIES: • Meets all requirements of the Clinical Research Associate (I) level. • Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities • May serve as a lead monitor for a protocol or project • Participates in initial and on-going protocol and CRF training • May serve as the Primary contact for the clinical sites/Sponsor • Participates in the generation of study specific monitoring plans and ICF templates • May participate in the development of protocols and Case Report Forms • Participates in the development of conventions for CRF transcription • May assist with the coordination of vendor services, including translation of study documents, when required • May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Qualification Visits • Will participate in Sponsor and Investigator/Initiation Meetings. • Track progress of projects and identify appropriate actions to achieve target objectives. • General on-site Monitoring Responsibilities: • Ensure study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements, as written. • Ensure the protection of subjects 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 CRFs or other data collection tools by careful source document review. • Ensure that the Site Regulatory Documents are complete and current throughout the duration of the trial. • Ensure that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements • 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. • Complete process of SAE reporting, process production of reports, narratives and follow up of SAE’s • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems. • May assist with training and development of new employees, e.g. co-monitoring • Available for travel, 70% or more of the time, including overnight stays. • Perform other related duties as assigned. **Position preferred location is Madison, WI or TBD (Texas region, or Midwest region).   Education/Qualifications: • University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology). • 5 – 6 years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, or data management), including 2 years Clinical Monitoring experience (prefer Phase I experience). • Thorough knowledge of ICH guidelines, GCP and the clinical trial process. • Knowledge of the drug development process • Thorough knowledge of Monitoring Procedures, including full understanding of the Serious Adverse Event reporting, report narratives and follow-up • Demonstrated ability to independently perform clinical monitoring responsibilities • Ability to work with other Covance business units. • Excellent planning and organizational skills. • Excellent verbal and written communication skills • Excellent study site management skills. • Good computer skills with good working knowledge of a range of computer packages including Electronic CRF processes. • Ability to identify project-related problems and prioritized workload • Basic understanding of statistical programming, data management, and clinical trial report preparation processes. • Valid Drivers License 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 committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us. Save to job file |