Covance is seeking experienced Clinical Research Associates / CRA to join our ECD-Phase I and Phase IIa team for General Medicine & Oncology!
Early Clinical Development fosters an environment that attracts, engages and retains scientifically-focused professionals. Our monitoring workforce is innovative, inquisitive, and committed to helping our clients make early clinical decisions sooner for their drug development strategy.
Duties and Responsibilities:
- Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities
- Participates in initial and on-going protocol and CRF training at study site
- May serve as the Primary contact for the clinical sites/Sponsor
- Participates in the generation of study specific monitoring plans
- May participate in the development of protocols and Case Report Forms
- Participates in the development of and/or review of
- May develop materials for site reference manual
- May assist with creation of site training materials conventions for CRF transcription
- May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Visits
- Participates in Sponsor and Investigator/Initiation Meetings
- Tracks progress of assigned studies/projects and identifies appropriate actions to achieve target objectives.
- Fulfills general on-site Monitoring Responsibilities:
- Ensures 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.
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
- Ensures that the Site Regulatory Documents are complete and current throughout the duration of the trial.
- Ensures that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Ensures 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.
- Prepares accurate and timely trip reports.
- Identifies and completes follow- up of SAEs at study site for which he/she is responsible
- Independently performs CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems.
- Assists with training of new employees, e.g. co-monitoring
- Performs other related duties as assigned.
Join our growing Early Clinical Development team and help bring the miracles of medicine to the market sooner!
**Seeking candidates nationwide**
Home Based positions must be willing to travel 80%
- University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
III. In lieu of the university /college degree or certification requirement, 4 or more years of relevant clinical research experience in pharmaceutical or CRO industry (North America , only)
- Thorough knowledge of ICH guidelines, GCP and the clinical trial process, is preferred.
- Project Coordination and/or project management experience preferred.
- Proficient computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
- Basic understanding of statistical programming, data management, and clinical trial report preparation processes is preferred.
IV. Recommended: Membership in and certification by a recognized, professional research organization (e.g., ICR, ACRP)
- Knowledge of the drug development process.
- Excellent verbal and written communication skills
- Valid Drivers License
Experience Required: North America and Europe
- 2 - 4 years of experience in a related field, including 1 - 2 years Clinical Monitoring experience.
- Additional experience may be substituted for education requirements.
EEO Employer 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.