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Abbott · 1 day ago

Scientist, Clinical Research

United States - Texas - Plano

Full-time

Onsite

Senior Level, Lead/Staff

$99K/yr - $199K/yr

8+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an experienced Clinical Research Scientist to provide scientific expertise throughout the development and implementation of clinical studies and evaluations. The role involves writing and managing clinical trial protocols, interacting with cross-functional teams, and ensuring regulatory compliance.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, and/or Senior Management and investigational sites as directed by your manager

Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff

Participates in site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members

Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines

Allocates resources by utilizing the appropriate project management tools.; 5. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process

Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction

Writes study protocols, protocol amendments, informed consents, clinical evaluation plans and reports, risk master lists, and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice

Interprets Phase I to IV clinical study results in preparation for new product applications by evaluating scientific literature and publications, analyzing scientific and risk data and staying abreast of current clinical practice

Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings

Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc

Participates in and supports audits

Qualification

Clinical trial protocolsClinical evaluationsRegulatory submissionsScientific publicationsProject managementAnalytical skillsCommunication skillsTeam collaboration