clinical case manager

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!   location: Lake Forest, Illinois job type: Contract salary: $40.00 - 44.67 per hour work hours: 9 to 5 education: Bachelors   responsibilities: Monitors activities conducted by study sites as they relate to Company non-interventional studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Company Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Provides timely, and complete monitoring reports including actions items and follow-up. Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Company Standard Operating Procedures (SOPs) and business processes.Overviews the overall activities of site personnel over whom there is no direct authority and motivates / influences them to meet study objectives. Proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures audit readiness at assigned sites.Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events, if applicable, by site personnel.Ensures safety and protection of study subjects through compliance with the study monitoring plan, Company SOPs, ICH Guidelines, and applicable regulations.Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.Manages investigator payments as per executed contract obligations.Manages site specific central IRB submissions and approval, including trackingMaintenance of site files with in the TMF.Manages site specific updates to CTMS systemsSite feasibility: at the direction of the study management team, evaluates and recommends new/potential investigators/sites on an on-going basis. to assist in the placement of planned study with qualified investigators/sites.  qualifications: Bachelor's degree in science or relevant field of study5 years of site Management and Monitoring experience, which includes a period of 2-3 years of non-interventional trial and remote/logic check monitoring experience. Note: both on-site and remote monitoring experience is required.Experience with Migraine or Migraine/gepant trials preferred. Neuroscience and pain management experience is a secondary preference.Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with deadlines.Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.Ability to use functional expertise and exercise good judgment.Demonstrated business ethics and integrity.  skills: SOP, CTMS, CTMS (Clinical Trial Management Systems), ICH Regulations, TMF 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Applications accepted on ongoing basis until filled.

job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!   location: Framingham, Massachusetts job type: Contract salary: $68.00 - 70.42 per hour work hours: 8 to 4 education: Bachelors   responsibilities: The HSE Associate Level Service Provider serves an important and highly visible role helping to ensure that site HSE Management System (HSE-MS) requirements are appropriately implemented and maintained necessary to ensure safe site operations. This is a full-time role.The HSE Associate Level Service Provider will support the Massachusetts R&D facilities to support site HSE Managers with the following HSE tasks and objectives:Implementing, monitoring, and participating in the development of site environmental, health and safety programs (Contractor Safety, Ergonomics, Laboratory and Chemical Safety, Hazardous Waste, Wastewater, etc.)Ensuring compliance with all applicable federal, state, and local environmental and occupational regulations and permits (Department of Environmental Protection, Occupational Safety and Health Administration, Massachusetts Water Resources Authority).Leading risk assessment processes, including, but not limited to job hazard analyses, hazardous chemical and ergonomics.Conducting comprehensive environmental, health and safety inspections of laboratories and facilities.Providing technical assistance and advice to laboratory managers and employees regarding environmental health and safety issues.Conducting accident/incident investigations.Serving as lead on certain environmental, health and safety projects.Providing initial in remote/in-person response to afterhours and weekend emergencies for initial size up.  qualifications: Bachelor's degree from an accredited four-year college or university Industrial Hygiene, Safety, Environmental Science or similarExperience 5-7 is ideal.They should have experience in completing site safety inspections, completing Job Hazard Analyses, chemical and hazardous waste knowledge, ergonomics, and biosafety experience is very helpful.They should be able to assist in influencing others, listening, and being problem solvers. Performing work that requires decision making and the consistent exercise of independent judgment and discretion.Effective communicator and solutions-oriented problem solverPrior HSE experience in academic or commercial R&D facilitiesFamiliar with HSE-MS concepts  skills: Health and Safety Monitoring 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.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Applications accepted on ongoing basis until filled.

job summary: Randstad Federal is seeking a Clinical Programmer in support of a Federal program with NIH   location: BELTSVILLE, Maryland job type: Contract salary: $30 - 37 per hour work hours: 8am to 4pm education: Bachelors   responsibilities: Requirements: BS/BA degree in computer science or a related field and 2 years of related experience; (additional experience (5 additional years) may be substituted for a degree) or a Master's and only 1 years of experience is acceptableC#, SQL, PL/SQL and/or SAS strongly desiredExperience with Medidata Rave custom functions is strongly desiredExperience with Clinical Reporting tools such as J Review is a plusAny experience with NIH intramural programs and an understanding of various data a submissions to government and commercial sponsors is a plusPermanent Residency or US Citizenship is required and the ability to obtain an NIH Public Trust clearance Responsibilities: Perform analysis, design, code and test of changes or enhancements to legacy clinical systemsBuild studies in Medidata Rave or other clinical data management systems including derivations and validation proceduresCoding custom functions with C# for Rave studiesDevelop study schema, forms, validation procedures and reports and document development workInvestigate production issues and provide solutionsInterface with QC, protocol analysts, clinical teams, and program management to clarify requirements and coordinate testingDevelop advanced reports using J Review, Oracle SQL, SAS and other toolsAssist in testing and evaluating new upgrades to technologiesPerform data submission (CTMS, CDUS) and data transmissions to multiple pharmaceutical sponsors   qualifications: Experience level: ExperiencedMinimum 2 years of experienceEducation: Bachelors  skills: PlanningJava 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.At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). Applications accepted on ongoing basis until filled.