GENERAL - Clinical Operations

Reports to: Director, Clinical Operations & Strategy
Salary range: 80-150/hr, depending on experience and level

Our team consists of all contract (1099) staff. When not hiring, we share what we do to meet like-minded folks so that when we expand, we can do so quickly. We are currently full but a typical Clinical Operations team member will primarily:

  • Perform monitoring and site management for up to 3 clinical trials simultaneously

  • Develop trial-specific plans (project plan, communication, monitoring, site mgmt, etc.)

  • Support build of EDC, CTMS, eTMF systems (support specifications, build, UAT, launch)

  • Maintain dashboards and reports as part of trial management in CTMS (will change per client and EDC vendor)

  • Manage clinical trial sites (support SQV, SIV, IMV, training, etc.)

  • Manage project plans, timelines, and deliverables for clients

  • Manage vendors (support contracting, meetings, coordination, deliverables, etc.) as needed

  • Support clinical trial reporting (cross-functional collaboration with Science team to develop and submit reports)

  • Support business development with proposals and presentations for prospective clients

  • As a small team with a variety of clients, we may need other support (like generating marketing collateral or supporting a regulatory submission) for our clients. This list is not exhaustive but is meant to be representative.

Required experience and qualifications:

  • At least 2 years’ experience working in clinical operations or research for regulated clinical trials

  • GCP certification

  • Ability to travel as needed (client trials vary so we cannot estimate travel requirements up front) to perform on-site qualification, initiation, monitoring, close-out visits

  • 2-5 years’ experience at or managing a clinical trial site (monitoring, data review, data entry, site coordination, etc.)

  • Demonstrated experience with ethics committee (IRB) submissions at commercial and academic sites (bonus: global submission experience)

  • Demonstrated ability to communicate effectively to and manage clinical trial stakeholders (PIs, coordinators, vendors, etc.)

  • Demonstrated experience with clinical trial management (e.g., project plan mgmt, ethics submissions, site management)

  • Education (at least undergraduate degree) or equivalent experience in anatomy, physiology, kinesiology, public health, or similar

  • Bonus: advanced degree in physiology, kinesiology, public health, or similar with thesis work focused on experimental design, data collection, analysis, and interpretation of human subjects research data 

  • Bonus: CCRP certification

  • Competency in Google Office Suite, Box, and similar collaborative platforms

  • Must be willing to work Pacific Time hours generally and be flexible for client meetings.

  • Must be located in and able to work in the United States. We cannot provide sponsorship at this time.

Soft skills required for success on our team:

  • Efficient time management - we operate as fractional support for our clients so tracking time, performing tasks on time/budget, communicating when more time is needed is essential to success in this role

  • Communication - a remote-first team, consistent, and thorough communication is key. We use a variety of communication platforms (WhatsApp, email, texting, video calls, telephone calls) to communicate internally. With clients and our teammates we start from a place of respect and understanding to communicate sometimes difficult topics. 

  • Context-switching - each teammate at ActiVie is expected to support up to 3 clients/projects simultaneously. This requires good documentation skills and the ability to switch between clients and projects. We know this takes mental bandwidth and encourage transparency, lots of documentation, and constant communication to ensure our team is supported and able to perform the role without burnout.

  • Project management - we are client-focused and as such need to manage our projects and clients. This includes task tracking, timeline management, and communication of progress/deliverables to the team/client which are often all over the world.

  • Critical thinking - we are brought in by early-stage or small companies to support their scientific strategy and clinical operations. This role will use their scientific acumen to support client clarity of project goals, timeline, deliverables and to advise on trial design or documents they may have developed.

  • Curiosity - we have a unique position in that we serve clients representing a variety of therapeutic areas and products. It’s more fun if this person is curious about these new products and loves learning!

  • Creativity - with limited time, resources, or potentially experience, we need to be able to provide clients with a way to meet their goals. This can mean getting creative about study design, data collection, conference targets, etc.!