Associate Director, Source

What We DoCare Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We AreWe care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find the latest ideas to accelerate medicine, and seed a long-term impact for generations.  Position OverviewAs the Associate Director of the Source Department at Care Access Research, you will assume a leadership role in overseeing, motivating, and project managing a team of dedicated professionals. Your primary focus will be to ensure the efficient and compliant management of source documents across our clinical trials. And to implement e-source platforms across the Care Access Global site network. This critical role requires a combination of leadership, project management, and clinical research expertise to drive success. What You'll Be Working OnDuties include but not limited to: Leadership and Motivation: Lead and inspire the Source Department to achieve departmental and organizational goals. Foster a culture of collaboration, accountability, and continuous improvement within the team. Provide guidance, coaching, and mentorship to team members, supporting their professional development. Project Management: Plan and implement e-Source platforms across the Care Access Global Site NetworkPlan, initiate, and execute projects aligning with study-specific requirements.Drive productivity, organize workloads, and plan resources to meet workload deliverables.Implement a robust project management system to coordinate deliverables.Track and supervise project progress, ensuring adequate resources, evaluating, and escalating risks, as necessary.     Documentation Management:Utilize protocols, case report forms, pharmacy manuals, and other essential documents to create comprehensive e-source builds/paper source templates tailored to study-specific needs from baseline templates.Verify the accuracy and completeness of data fields and templates within the software.Maintain a detailed audit trail of revisions. Quality: Ensure that source documents adhere to GCP (Good Clinical Practices) guidelines, 21 CFR Part 11 Compliance, and Care Access Research Internal Standard Operating Procedures (SOPs). Implement quality control processes to maintain the accuracy and completeness of source documents. Conduct regular reviews of templates to identify and address compliance issues. Resource Management: Allocate department resources effectively to support multiple clinical trials simultaneously. Assess staffing needs and participate in recruitment efforts, as necessary.Manage department budgets and expenditures. Stakeholder Engagement: Collaborate with internal and external stakeholders, including site staff, sponsors, and regulatory authorities, to ensure seamless source document management.Address inquiries and concerns promptly and professionally. Reporting: Generate comprehensive reports to present to leadership on productivity and improvement initiatives. Ensure deliverables for Sponsored projects meet expected quality standards.Keep leadership fully informed of any projects that may impact the quality or timeliness of project delivery to customer satisfaction. Physical and Travel Requirements·       This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.  What You BringKnowledge, Skills, and Abilities: ·       Strong understanding of GCP guidelines and 21 CFR Part 11 Compliance.·       Expert experience in e-Source systems (CRIO/Clinical Conductor e-source). ·       Prior experience in clinical research essential.·       Proficiency in document management systems and software.·       Expert experience in change management of systems·       Excellent attention to detail and organizational skills.·       Effective communication and interpersonal skills.·       Ability to work collaboratively in a cross-functional team environment.·       Proven leadership and team management skills·       Strong project management expertise, including the ability to manage multiple projects simultaneously. ·       Excellent problem-solving skills.·       Exceptional communication and interpersonal skills Certifications/Licenses, Education, and Experience: ·       Bachelor's degree in a relevant field (Life Sciences, Healthcare, or related discipline).·       At least 5 years of experience in clinical research, with growing responsibilities.  Benefits (US Full-Time Employees Only)●      PTO/vacation days, sick days, holidays. ●      100% paid medical, dental, and vision Insurance. 75% for dependents.●      HSA (Health Savings Account) plan●      Short-term di