Oncology Clinical Research Associate
The clinical research associate completes project activities associated with monitoring functions of phase i-iv clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (sops).
-knowledge of applicable sops, guidelines and study procedures.
-assist with protocol and crf review.
-develop informed consent forms.
-conduct study feasibility and site selection activities.
-assist with the development of study manuals, annotated crfs, monitoring conventions, tracking forms, site study tools, and other study materials.
-develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities.
-assist with investigator meeting activities including organization, preparation and attendance.
-conduct site management activities, including but not limited to site qualification visits, site initiation visits, site training, site interim monitoring visits, and site close out visits.
-perform co-monitoring visits and performance assessment visits, when properly trained and delegated by clinical research manager
-ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
-establish and maintain good rapport with study sites.
-write study visit reports and follow up letters within the timeline established by applicable sops and guidelines
-coordinate timely shipment of clinical supplies and study drug to sites.
-ensure proper storage, dispensation and accountability of clinical supplies and study drug.
-maintain adequate site tracking records.
-follow up of drug safety issues and safety reports in timely manner, if applicable.
-communicate site study issues, concerns, and progress to clinical research manager, project manager and clinical team lead accordingly.
-assist with data query form (incl. Query process).
-perform telephone monitoring activities in order to obtain study status information.
-development and implementation of corrective actions when appropriate.
-prepare/review all patient tracking records.
-input and maintain study information concerning subject status of financial reimbursement to sites.
-mentor for site manager and/or site manager ii, when assigned
-conduct on the job training and formal training to other site managers.
-collaborate with clinical research manager/ study teams to resolve site issues
-review study visit reports, follow-up letters and site communication generated by other site managers for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from clinical team lead or clinical research manager as needed.
-bachelor’s degree, preferably in allied health fields: medical, nursing, pharmacy, psychology, veterinary or health science.
-minimum of 4 years of clinical research experience; preferably in clinical research monitoring of international, multi-center clinical trials in multiple therapeutic areas.+19 Other Responses
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