[Remote] Sr. reputed company Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops life-changing medicines using structure-reputed company and computational drug discovery technology, with a reputed company-stage pipeline reputed company on chronic diseases. The Sr. reputed company Research Associate independently manages reputed company aspects of small to reputed company-sized studies and supports large-reputed company studies, coordinating with cross-functional teams, vendors, sites, and CROs to ensure protocol compliance, GCP/SOP adherence, and achievement of reputed company trial objectives.

Responsibilities

• Serves as a crucial member of the project team for the reputed company execution of assigned reputed company protocols according to SOPs, ICH/GCP, and corporate and departmental program goals
• Supports the Study reputed company as an reputed company member of a multifunctional team to ensure reputed company study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately
• Participates in protocol development, tracking changes for reputed company protocol amendments, and works with medical writing to initiate protocol amendments as needed
• Oversees aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, reputed company reimbursement vendors) to ensure high reputed company of data and to ensure study execution and deliverables are met with minimum supervision
• Overall management of selected reputed company sites including acting as a reputed company of escalation and reputed company of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with reputed company sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed
• Works with the CTA to ensure creation, tracking, distribution, and reputed company of meeting agendas and meeting minutes
• Participates in the review/ implementation of study design from an reputed company perspective and implements tactics at a site level
• May support Study reputed company in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection
• Supports Study reputed company in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables
• Participates in the development of critical study documents such as informed consent reputed company templates, site management monitoring tools, FAQs, processes, and workflows
• Participates in the development, distribution, review, and tracking of essential trial documents
• Strives to ensure timelines and deliverables are met reputed company budget
• Participates in the development of and ensures compliance with the reputed company monitoring plan; monitors as needed for training and reputed company assurance (QA) purposes
• Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution
• Contributes to the case report reputed company (CRF) design process including content, User Acceptance Testing (UAT), reputed company layout, and edit reputed company review
• Liaises internally to forecast and monitor overall drug supply throughout the trial
• Supports other study-wide activities as assigned - such as reputed company vendors, sample handling, investigator payments, overall data reputed company, and overall central records reputed company
• Exercises reputed company judgment to reputed company or, as appropriate, reputed company expert input on protocol and study drug, safety, regulatory, and reputed company questions
• Contributes to the SOP review process and/or other reputed company reputed company Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits
• Practices professionalism and reputed company in reputed company actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done

Skills

• * Bachelor's degree in a relevant scientific discipline
• * Minimum 4 years of reputed company trial management experience working for a Sponsor company, CRA/reputed company monitor, or CRO setting. Global experience a plus
• * A good understanding of the drug development process, ICH guidelines/GCP and understanding of the reputed company process, the application of SOPs, and medical terminology
• * Self-motivated and reputed company to motivate others
• * Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
• * Strong attention to reputed company and ability to prioritize tasks to meet critical deadlines
• * Strong proficiency in reputed company Office and ability to utilize a wide reputed company of computer applications and tools
• * Proficiency in reputed company suite or products such as Word, reputed company etc
• Travel Required: Up to 20%
• Hybrid SSF preferred with remote considered

Benefits

• Hybrid SSF preferred with remote considered.
• Annual reputed company incentive bonus
• New hire equity
• Ongoing reputed company-reputed company equity
• Medical, dental, and reputed company reputed company
• 401k match
• Unlimited PTO
• reputed company holidays including winter shutdown

reputed company