(Oncology) - 1 year
- 4+ years Bachelor Degree
- Assists in the operational activities involved in the planning, conduct and completion of clinical trials.
- Uses independent action and judgment to complete these activities.
Such activities include:
- Estimating and ordering clinical supplies
- Establishing target dates for completing of assignments
- Collection, review and filing of clinical trial documents (e.g., monitoring guidelines, investigator site file and draft informed consent)
- Preparation of essential trial meeting (e.g., trial preparation meeting, investigator meeting)
- Developing the screening rules with data management and the Trial Clinical Monitor
- Tracking and requesting grant payments
- Communication with investigative sites on routine matters concerning on-going trials
- Handling request for trial related information
- Adheres to governmental regulations and company SOPs when executing assignments
- Working closely with data management, the clinical monitor and/or medical supervisor, the Senior Medical Research Associate performs the in-house review of clinical trial data to ensure the completeness, accuracy and consistency of the trial data.
- Ensures that all data discrepancies are resolved.
- Uses independent action and judgment during the process.
- Seeks input on issues requiring medical judgment.
- Responsible for in-house management of investigative sites.
- Assists the clinical monitor and /or medical supervisor in preparing clinical trial protocols, writing non-driven data sections of clinical trial reports and in the review and reconciliation of serious adverse event narratives.
- Develops implements and continually reviews tracing systems for assigned projects to assure that timelines are being met as anticipated.
- Develops and maintains an active liaison with members of other groups involved in the drug development process, particularly data management and clinical field operations, and participates in Clinical Trial Team meetings. "
About Precept Life Sciences:
Precept Life Sciences is a premier professional workforce solutions firm headquartered in Sterling, Virginia. Established in 1999, Precept possesses a proven track record of providing key talent for the dynamic Life Science industry within North America. With over 70 years of combined recruiting experience, our team consists of degreed scientists who quickly comprehend complex technical requirements, enabling us to accurately identify the right talent for you. Precept specializes in supporting the Pharmaceutical, Biotech, Medical Device, CMO/CRO industries within the following skill sets. From single placements to comprehensive workforce solutions projects, Precept is committed to offering the right-sized solution for our customers. Simply put, we strive to be your most valued resourcing partner operating within our core values; Integrity, Excellence, Expertise, Results.