[Remote] Sr. Clinical Research Associate (MP)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The Sr. Clinical Research Associate will independently manage reputed company clinical aspects of small to reputed company-sized clinical studies, ensuring compliance with protocols and good clinical practices while collaborating with a cross-functional team.
Responsibilities
- Serves as a crucial member of the project team for the reputed company execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals
- Supports the Study reputed company as an integral member of a multifunctional team to ensure clinical 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, patient 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 clinical 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 clinical 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 accuracy of meeting agendas and meeting minutes
- Participates in the review/ implementation of study design from an operations 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 clinical 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 external vendors, sample handling, investigator payments, overall data reputed company, and overall central records reputed company
- Exercises reputed company judgment to resolve or, as appropriate, reputed company expert input on protocol and study drug, safety, regulatory, and legal questions
- Contributes to the SOP review process and/or other Clinical Operations 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 clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus
- A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials 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 detail 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
Benefits
- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
- Medical, dental, and reputed company insurance
- 401k match
- Unlimited PTO
- A number of reputed company holidays including winter shutdown
reputed company