Randstad Clinical Study resource II in Northbrook, Illinois
Clinical Study resource II
salary:$39.23 - $46.15 per hour
date posted:Tuesday, May 14, 2019
industry:Professional, Scientific, and Technical Services
Clinical Study resource II
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location: Northbrook, Illinois
job type: Contract
salary: $39.23 - 46.15 per hour
work hours: 9 to 5
Responsible for internal Clinical Study Management between CRO and internal study team members throughout the study process.
Processes and reviews various study and study related governance documents.
Collaborates with the CRO to develop reporting tools that clearly show study progress or lack thereof.
Leads the internal study team via scheduling and conducting weekly meetings to include minutes.
Attends weekly CRO call and relays items needing attention of study team via weekly internal study meetings.
Responsible for operational support of medical affairs sponsored studies to include management of study budget and vendor contracts.
Scope may include 1-2 different product programs representing up to 3-4 different Phase IV sponsored clinical and/or non-interventional trials.
This role will collaborate with 1-2 medical directors, study team members in Medical and Development and the CRO team.
Oversees CRO as contracted for the following services:
Assures that CRO monitors clinical sites to ensure adherence to protocol (including appropriate patient selection) and safety requirements.
Ensures accuracy and completeness of the data in CRFs and that CRO provides prompt resolution of data queries.
Monitors CRO reports trends and observations noted at sites to study team.
Ensures prompt processing and monitoring of drug requests for CRO depot supplies.
Ensures that CRO and Sponsor have received and processed SAE information from Investigators as required.
Identifies protocol modifications as needed.
Provides necessary study updates to internal study team on a regular basis.
Monitors CRO study close out visit activities ensuring that required documents are in order.
Ensures that CRO: Establishes and maintains working relationship with study coordinators and investigators at assigned study sites.
Ensures the delivery of all supplies and equipment to assigned study sites.
Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.
Performs SIVs, IMVs and Close out Visits.
- Collaborates with CRO in identifying study sites, developing feasibility questionnairres and training documents for CRO personnel to perform pre-study visits.
Document Preparation, Processing and Review:
Evaluates and reviews clinical data. Assists in developing and reviewing CRFs, creating site administrative binders and developing monitoring tools.
Reviews data listings for accuracy and completeness.
Demonstrates an understanding of assigned protocols including therapeutic area, study drug and Investigator Brochure or package insert.
May draft materials including informed consent documents, protocols, patient instruction guides and case report forms.
Assists the Clinical team in the preparation and execution of study plans (e.g., monitoring plan, communication plan, etc.); supports the internal set-up of trial management systems in support of the clinical study.
Collaborates with CRO to create and maintain various study trackers.
Direct CRO to and maintain access to final data repository.
BA/BS (natural/clinical science major strongly preferred) with typically at least 2 years of clinical study management experience (or 1+ years with Masters or Ph.D. degree).
Experience managing Phase 4 sponsored studies.
Knowledge in reference to good clinical practice, regulations and standard operating procedures in the pharmaceutical industry.
Prior experience in pharmaceutical study management
Excellent interpersonal, written and verbal communication and computer skills (Microsoft Office).
Experience in the pharmaceutical field.
3+ years clinical research experience
skills: CRF, Phase I, Phase II, Phase iii, Phase iv, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, COV (Close-Out Visit), RMV (Routine Monitoring Visit), SIV (Site Initiation Visit), SAE (Serious Adverse Event)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.