research specialist i, clinical insights.

　　hopkins , minnesota (remote)

　　posted 10 days ago

　　job details

　　summary

　　$25 - $31.51 per hour

　　contract

　　bachelor degree

　　category life, physical, and social science occupations

　　reference47266

　　job details

　　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: Hopkins, Minnesota

　　job type: Contract

　　salary: $25.00 - 31.51 per hour

　　work hours: 9 to 5

　　education: Bachelors

　　responsibilities:

　　Come join the company's Urology Clinical Sciences organization where we partner together to advance Urology for patients. We are looking for a Clinical Research Specialist I to join our Urology Clinical Insights team. This role supports key commercialized products by coordinating Investigator Sponsored Research and Collaborative Clinical Research activities and driving long-term evidence strategies. This role coordinates and oversees the management of Investigator Sponsored Research Studies and Collaborative Clinical Research Studies from initiation to closure by maintaining all documentation pertaining to research activities, initiating and executing both contract agreements and payments to enable funding of research activities, monitoring and documenting research progress.

　　Coordinate and oversee the management of Investigator Sponsored Research and Collaborative Clinical Research from initiation to closure.

　　Ensure compliance with Investigator Sponsored Research and Collaborative Clinical Research procedures and policies.

　　Coordinate with cross-functional teams, including regional Medical Affairs teams (US, Europe, Asia, Latin America), Finance, Legal, Medical Safety, Regulatory Affairs, R&D, Scientific Communications, and Biostatistics.

　　Serve as the point of contact for investigators and study sponsors.

　　Process submissions of study concepts and proposals in the IdeaPoint system to ready them for stakeholder review.

　　Review submissions for completeness through the review of study protocols, budgets, and other required documentation.

　　Prepare monthly agendas for ISR committee meetings and meeting minutes from ISR committee meetings.

　　Coordinate the drafting, negotiation, and execution of Investigator Sponsored Research and Collaborative Clinical Research Agreements between Boston Scientific and Healthcare Institutions.

　　Monitor and document study progress, addressing issues and ensuring timelines are met.

　　Coordinate payments and product shipments outlined in Investigator Sponsored Research and Collaborative Clinical Research Agreements.

　　Maintain up-to-date information in the IdeaPoint system and internal tracking documents for each study.

　　Participate in audits and inspections related to Investigator Sponsored Research and Collaborative Clinical Research activities.

　　Support strategic growth of the Clinical Insights team's Real-World Evidence (RWE) capabilities

　　Supporting the design, planning, and execution of retrospective data analyses of patient chart data, third-party registry data, insurance claims data, and/or user feedback data relating to commercialized company Urology products

　　Support the writing of research protocols and reports and contribute to other documents as needed.

　　Participate as a key team member on process development and improvement efforts to meet Urology VIP goals.

　　Support business critical projects relating to EU MDR and Acquisition Integrations.

　　In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

　　For those individuals that supervise others, the following statements are applicable:

　　Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Quality Policy.

　　Establishes and promotes a work environment that supports the Quality Policy and Quality System.

　　qualifications:

　　Minimum Qualifications

　　Bachelor's Degree (Clinical/Research, STEM or related) and 1+ years of related work experience (including ISR coordination, grant coordination, medical affairs, clinical trial operations, clinical safety, quality assurance or regulatory affairs)

　　Ability to work in a team environment and possess clear, concise communication skills - written and verbal

　　Excellent organizational and problem-solving skills

　　Preferred Qualifications

　　Medical device or Clinical experience relating to Urology

　　Experience with Investigator Sponsored Research, Collaborative Clinical Research, or Grant programs

　　Familiarity with ICD-10 and CPT Urology-related codes

　　Scientific writing experience

　　Physician-facing experience

　　skills: Quality Assurance

　　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 [email protected].

　　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.