
Regulatory Affairs Coordinator
14 hours ago
Role Summary
">This is an exciting opportunity to join our team at Dmclinicalresearch as a Study Start Up Specialist. The successful candidate will play a key role in managing the portfolio of active and future studies, bringing pipeline opportunities to activation within defined timelines, and participating in process improvement strategies for all stakeholders.
">Responsibilities
">- Establish and maintain effective relationships with Sponsors/CRO's & Key Stakeholders for study start-up activities, ensuring open communication and collaboration.
- Prepare and prioritize correspondence via email to sponsor level, guaranteeing timely and responsive communication.
- Maintain a thorough understanding of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents and study protocols, staying current on relevant changes and updates.
- Ensure the secure handling of sensitive and confidential information, maintaining confidentiality and integrity.
- Participate in study start-up team meetings as necessary, fostering open communication and collaboration among team members.
- Utilize Study Start Up platforms to track activities, develop reports, and analyze data, providing valuable insights to inform decision-making.
- Support the on-site clinical operations team with start-up activities, providing study startup updates to management and site staff, and facilitating effective communication.
- Monitor Study Start Up Timelines, tracking all startup milestones, meeting deadlines, and driving outcomes follow-up with applicable stakeholders to ensure resolution.
- Report project status and issues to Senior Project Manager on a regular basis, ensuring transparency and accountability.
- Collaborate with Sponsor/CRO vendor management for site readiness, ensuring seamless coordination and execution.
- Act as a subject matter expert on all SSU related activities, overseeing and leading activation activities.
Requirements
">- A minimum of 3+ years of clinical research experience.
- Experience with ICH/GCP documentation and process preferred.
- Experience working in the clinical research industry and knowledge of the clinical trials process required.
- Experience in Study Start-Up activities, activation, supplies & accesses delivering high-quality work in a dynamic environment.
Working Conditions
">Flexible and willing to provide cross-functional support. Ability to manage multiple tasks simultaneously and meet deliverables deadlines in accordance with Study Start-Up timelines. Be detail-oriented and demonstrate attention to detail with ability to use critical thinking skills to proactively identify and solve problems. Excellent oral and written communications skills. Strong presentation, documentation and interpersonal skills. Proficient computer skills including Word, Excel (Advanced), Power Point, Adobe Software and Google Sheets. Strong prioritization and time management skills.
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