Senior Specialist, Trial Site Support & Operations

Cambridge, MA, USA • Virtual Req #28

Tuesday, June 18, 2024

POSITION TITLE: Senior Specialist, Trial Site Support & Operations

LOCATION: Remote US

This position reports to our global HQ in Cambridge, MA and is fully remote within the US. Travel is expected when needed and local candidates are preferred.

The TriNetX platform efficiently serves industry and care providers to conduct more efficient clinical research. Through the CONNECT service, member hospitals get informed on new clinical trials that originate from our industry partners and can engage on those opportunities which are of high interest to them.

TriNetX aims to expand this service with personalized clinical trial support towards its hospital members (TriNetX Premium Trial Site Program). Under this pilot program, dedicated TriNetX Health Care Partner Managers will closely collaborate with our member hospitals in a staff augmentation-like model, assisting clinical staff with use of the TriNetX platform for engaging in clinical studies.

• You will support the Clinical Research Center (CRC) or equivalent departments at 4 to 5 assigned hospitals on behalf of TriNetX.
• Your aim is:

• • To maximize the participation of the hospital in studies and other projects initiated through TriNetX.
  • To make "your" hospital a top performer on the TriNetX network, maximizing value of their membership both for the hospital and our industry partners.
  • To build a network of contacts within designated hospitals to understand site operations, workflows and eliminate traditional barriers to project success

• You will comply with all rules, regulations, administrative registration, certifications and trainings that the assigned hospitals mandate in order to operate in a (virtual) "staff augmentation" model.
• You will be responsible for managing the TriNetX CONNECT service within the assigned hospitals (ie. managing study opportunities, liaising internally with the hospital, TriNetX and sponsors).
• You will facilitate participation of your assigned hospitals in clinical studies sponsored by our pharma and CRO clients by timely assessing incoming study opportunities or requests for information (CONNECT) based on hospital capabilities, patient population, and research interests; together with CRC/hospital staff.
• You will promote TriNetX by supporting the CRC/hospital with trial feasibility and patient identification and eligibility checking though use of our platform.
• You will develop proficiency and expertise in TriNetX platform usage including Connect and protocol design using Query Builder
• You will serve as the key point of contact for clinical projects, participating in recruitment and study participant selection using the TriNetX interface when appropriate
• You will build a professional relationship with all relevant stakeholders and individuals in the hospital to achieve your goals (eg. CRC, clinical departments, individual PIs, ...).
• You will help shape the program from its conception, contributing to the design, refinement and roll-out, guiding and connecting the dots for further stages of program implementation.
• You will bridge both sides, serving as the liaison between TriNetX and the hospitals you support.
• Internally, you will be the subject matter expert on aspects of clinical trial site operations and over time, TriNetX Connect, supporting operational oversight/KPI surveillance alongside serving as a consulting resource for the global healthcare network & commercial teams
• Finally, as a de-facto member of the CRC/hospital team, you will provide feedback to TriNetX on how the hospital partnership can be further strengthened and how we can bring additional value to our partners.

• A minimum of 5-7 years' relevant training and experience resulting from prior operational clinical research roles within healthcare or sponsor organizations.
• You will have experience and have had oversight in the following: pre-study evaluation, study initiation, treatment observation or study close out (suitable prior job roles include site clinical research coordinator/practitioner, research nurse, research pharmacist, site research compliance lead, clinical research associate, site relationship manager, site feasibility lead)
• Experience with the use of EMR/specific tools for feasibility and patient recruitment.
• Experienced working with principal investigators within varied therapeutic areas and departments, aiding in strategy to integrate clinical research within hospitals.
• Demonstrated knowledge and competency in GCP, understanding of site compliance with research protocols and regulatory requirements.
• Knowledge of medical terminology, procedures, medications, coding, public health/healthcare, clinical research ecosystem.
• Experienced in training of subject matter, including but not limited to the development of new materials for educational purposes.
• Strong business acumen, oral and written communications skills, and the ability to successfully interface and build relationships at all levels in the organization.
• Ability to work closely with, maintain accountability for, and influence related cross functional groups and other internal and customer stakeholders.
• Highly collaborative team player who can adapt to the needs of internal and external teams as they shift.
• Possess strong project management skills with experience in influencing across a variety of stakeholders.

• Professional healthcare qualifications/registration where applicable
• Bachelor's degree or higher (graduate degree or advanced certifications preferred)

• Use of Electronic Health Records or Real-World Data in feasibility & site identification
• Prior user of the TriNetX platform as part of current or previous job role

• Pay Type Salary