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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!   location: Cambridge, Massachusetts job type: Contract salary: $75 - 80 per hour work hours: 9 to 5 education: Masters   responsibilities: The company is seeking a Contractor, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to the company's Associate Director of Oncology, Clinical Biomarkers. This position will work collaboratively across biomarker, translational, etc, teams (internal, external CROs) to ensure planning, execution and data delivery of biomarker lab data for clinical trials conducted by the company. Bring in depth knowledge and technical expertise in variety of biomarker assays focusing in immuno-oncology area, such as NGS, scRNAseq TCR sequencing, immunogencity and othersOversee assay development/implementation efforts in clinical biomarker team by partnering with preclinical and clinical biomarker lab teams to understand current assay status and potential vendor or internal laboratory requirements for oncology programs.Responsible for overseeing vendors for timely and accurate completion of tasks and troubleshoot issues as it develops.Develop and provide operational input and recommendations into all study related documentation (including protocol, lab manual, informed consent form, and amendments) and processes, and ensure collection, delivery and analysis of bio-samples in compliance with these documents as well as GCP/ICH as neededContribute to evaluation of biomarker vendors by providing technical expertise in biomarker assays  qualifications: MS (with at least 6 years pharmaceutical/biotechnology experience) or PhD (with at least 1 year of pharmaceutical or biotechnology experience) in a related science focus (i.e. immunology, Oncology).Hands on experience in biomarker assays such as NGS, RNAseq, TCRb sequencing, scRNAseq, cell based immunogenicity assays are required.Experience in clinical biomarker CRO management is required. Knowledge in relevant biomarker assay qualification/validation, familiarity with assay development under regulated environment (CLIA, GCP/GCLP or equivalent) is preferred.Solid experience in the application of biomarkers during clinical development including experience with clinical translational research, development, validation and implementation of biomarkers in the Oncology space.Strong communication, organization and record keeping skills are required.   skills: GLP (Good Laboratory Practice), GCP (Good Clinical Practice) 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). This posting is open for thirty (30) days.

Exciting Opportunity: Budgets Analyst for Clinical Research Are you ready to make a significant impact in the world of clinical research? Join our innovative team as a Clinical Research Budgets Analyst and play a crucial role in advancing medical science! You will be at the forefront of preparing and maintaining budget templates for sponsored clinical trials, ensuring timely and accurate financial planning. Your main responsibilities will include: Reviewing new study routing forms and essential start-up documents. Conducting itemized cost analysis and interpreting clinical protocols into budget milestones. Providing precise patient cost descriptions for ICF submissions to the IRB. Updating budgets, milestones, and ICF information as necessary per contract/protocol amendments. In this dynamic role, you'll collaborate closely with our coverage analysis team, contract analysts, regulatory team, program managers, and internal finance groups. You'll manage a high volume of work across multiple research programs, each with unique functions. If you're detail-oriented, passionate about clinical research, and ready for an exciting challenge, we want to hear from you! Apply today to join our dedicated team and make a real difference in the future of healthcare. FOR MORE IMMEDIATE CONSIDERATION, email a current resume to iris.levy@randstadusa.com TXT: Your NAME and BUDGET to 954-308-6735  salary: $39 - $39.5 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorsResponsibilities Responsible for the development of study budgets from clinical studies protocols and using various software tools. Will complete full evaluation and integration of internal cost during the set-up of a new clinical study; will revise study budgets following revision of study protocols or re-assessment of study cost. Utilize and oversee research rate pricing for PH&S services rendered as part of a clinical trial. Communicate with Contracts Analysts to integrate study budget information into clinical trial agreements; may initiate or participate in contract negotiation process. Independently initiate or update the coverage determination for each study as applicable and communicate specific study billing structure to the clinical teams and service providers. Participate in the administration of study-subject related billing as needed and provide support with the auditing of billing records. Collects and maintains complete records and statistics on expenses and payments; regularly monitors compliance of clinical expense to pre-determined budget/billing plan and/or budgets and agreements. Establishes and promotes positive working relationships within both ORA and the research departments, throughout the hospital and between other institutions involved in clinical research. Responsible for the set-up of study payments milestones and Billing Instructions grids using Microsoft Applications (Excel) and/or the Clinical Trial Management System. SkillsBudgetBudgetingclinical studies (3 years of experience is required)accounting (2 years of experience is required)QualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. 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).This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Exciting Opportunity: Clinical Research Budgets Analyst Are you ready to make a significant impact in the world of clinical research? Join our innovative team as a Clinical Research Budgets Analyst and play a crucial role in advancing medical science! You will be at the forefront of preparing and maintaining budget templates for sponsored clinical trials, ensuring timely and accurate financial planning. Your main responsibilities will include: Reviewing new study routing forms and essential start-up documents. Conducting itemized cost analysis and interpreting clinical protocols into budget milestones. Providing precise patient cost descriptions for ICF submissions to the IRB. Updating budgets, milestones, and ICF information as necessary per contract/protocol amendments. In this dynamic role, you'll collaborate closely with our coverage analysis team, contract analysts, regulatory team, program managers, and internal finance groups. You'll manage a high volume of work across multiple research programs, each with unique functions. If you're detail-oriented, passionate about clinical research, and ready for an exciting challenge, we want to hear from you! Apply today to join our dedicated team and make a real difference in the future of healthcare. FOR MORE IMMEDIATE CONSIDERATION, email a current resume to iris.levy@randstadusa.com TXT: Your NAME and BUDGET to 954-308-6735  salary: $39 - $39.5 per hourshift: Firstwork hours: 8 AM - 5 PMeducation: BachelorsResponsibilities Responsible for the development of study budgets from clinical studies protocols and using various software tools. Will complete full evaluation and integration of internal cost during the set-up of a new clinical study; will revise study budgets following revision of study protocols or re-assessment of study cost. Utilize and oversee research rate pricing for PH&S services rendered as part of a clinical trial. Communicate with Contracts Analysts to integrate study budget information into clinical trial agreements; may initiate or participate in contract negotiation process. Independently initiate or update the coverage determination for each study as applicable and communicate specific study billing structure to the clinical teams and service providers. Participate in the administration of study-subject related billing as needed and provide support with the auditing of billing records. Collects and maintains complete records and statistics on expenses and payments; regularly monitors compliance of clinical expense to pre-determined budget/billing plan and/or budgets and agreements. Establishes and promotes positive working relationships within both ORA and the research departments, throughout the hospital and between other institutions involved in clinical research. Responsible for the set-up of study payments milestones and Billing Instructions grids using Microsoft Applications (Excel) and/or the Clinical Trial Management System. SkillsBudgetBudgetingclinical studies (3 years of experience is required)accounting (2 years of experience is required)QualificationsYears of experience: 2 yearsExperience level: ExperiencedRandstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. 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).This posting is open for thirty (30) days. Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.