- Job Title
- Clinical Coordinator
- Job ID
- Work From Home
- Boston, MA 02210
- Other Location
About Activ Surgical
Founded in 2017, is a first-of-its-kind digital surgery company providing previously unavailable data, enabling clinicians to make consequential decisions in real-time.
Activ Surgical is building a platform for introducing the latest sensing technology to minimally invasive surgery, intended to visualize the invisible to facilitate better surgical decisions and outcomes.
The supports the CSMO in planning and coordinating activities in all aspects of clinical trial operations. This position requires appropriate interpretation of significant policies and procedures. It involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.
Manager of Clinical Operations, ultimately to Chief Science & Medical Officer (CSMO)
- Plan, coordinate, and arrange study communications and critical meetings on and off-site with both internal and external attendees. Responsible for drafting Meeting Agendas and detailed Meeting Minutes for review and approval by Clinical Project Manager/Clinical Program Manager.
- Set up, update, maintain and close Trial Master Files. Assures currency and accuracy of required clinical trials documents (i.e., CVs Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements, etc.).
- Maintain project-specific regulatory document inventory systems which include a precise quality check (QC) process when documents are received.
- Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolved payment inquiries from investigator sites.
- Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions, and follow-up visit reminders as directed by CSMO.
- Create, populate, review, approve, distribute, and track study materials as assigned by the CSMO.
- Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.
- Liaison to clinical and multifunctional teams to resolve issues with submitted essential documents required for trial activities.
- Create and manage study materials, including newsletters, study templates, supplies etc. under the direction of initially CSMO.
- Actively and proactively participate and contribute ideas in the development of department initiatives and goals that will make a difference in the efficiency and effectiveness of clinical operations.
- Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.
- Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.
- Supports the team to ensure timely invoice processing
- Under guidance of Clinical Operations management, interact with internal and external clients to coordinate the accomplishment of business needs.
- Up to 30% travel as needed
- BS, nursing degree or higher degrees with 3-5 years relevant clinical research experience working at an Investigator Site, Sponsor or Clinical Research Organization.
- Familiarity of clinical trial operations, statistical analysis, ICH, GCP Guidelines and other applicable Regulatory requirements.
- Good working experience in a team environment across multi-functional areas.
- Highly organized, self-motivated, detail-oriented, proactive and accurate. Ability to work with urgency and thrive in a high-energy, fast-paced startup environment.
- Demonstrate excellent communication, verbal and written, and interpersonal skills.
- Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Publisher.
- Experience creating Clinical Trial Communications (newsletters, etc.), detailed PowerPoint presentations strongly preferred.
- Experience working with eTMFs and CTMS systems strongly preferred.