C
Sr. Clinical Operations Manager
CPC Clinical Research
4h ago
0$95k - $119kManagementAurora, CO, USjobspy_indeed
remoteindeed
Job Description
**We are looking for an experienced Sr. Clinical Operations Manager to join our team!**
Are you well organized, but adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day\-to\-day tasks? If the answer is yes, keep reading!
This role serves as the primary point of contact for industry sponsored clinical trials as well as any additional assigned projects.
Remote candidates are welcome to apply.
**General Responsibilities:**
* Work closely with the Head of Research and Community Health Operations and Head of Endpoint and Specialty Services to ensure overall quality of project services, proactive issue resolution and development of systems to standardize and improve project management practices as well as the whole ARO’s efficiency.
* Serve as a mentor to other Clinical Operations Managers, including providing guidance on what efforts and activities are required to ensure the overall quality of project services and deliverables.
* Oversee clinical operations management activities when delegated to a Clinical Trial Manager (CTM). For single\-site or smaller multi\-center studies in which these activities are not delegated to a CTM:
* Manage site identification, evaluation, initiation, contracting/budget negotiation, and site monitoring processes as required by contract.
* Identify the required regulatory documents for investigational product (IP) release and oversee documents collection.
* Prepare central IRB submissions; oversee site IRB approvals and ensure collection of all new or expiring Investigator regulatory documents after site activation.
* Oversee the development of project\-specific essential documents for site oversight and development of site materials.
* Review and finalize monitoring visit reports and follow\-up letters with Clinical Research Associates (CRAs).
* Work with CRAs on overall site management including identification, and resolution of site related compliance issues.
* Prepare study enrollment reports and review site issues with the project team.
* Manage and approve site payments as applicable.
* Contribute to process improvement, including but not limited to review and/or development of SOPs, and development and/or implementation of methods to improve quality of sponsor deliverables.
* Define and monitor project scope, timelines and deliverables from project initiation to close\-out in collaboration with the Head of Research and Community Health Operations.
* Identify project\-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation.
* Oversee trial\-related activities and provide performance feedback to supervisors for all project team members.
* Participate in the review, development and testing of study databases.
* Provide investigational product or device tracking and disposition as required by project.
* Develop and manage site and vendor contracts including investigati
