Clinical Site Relationship Manager

Clinical Site Relationship ManagerA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionJob Title: Site Relationship ManagerLocation: Cambridge, MADuration: 3 Year+ (Possible Ext.)Job Responsibilities:The Site Relationship Manager (SRM) within Value Based Medicine (VBM) will be responsible for the overall US site management, training and quality oversight of assigned studies. These studies will explore new technologies to generate, collect and present patient data seamlessly within the clinical practice setting. The goal of the studies is to explore innovative ways to learn from clinical practice and generate insights that can be used to inform decision making at the point of care. The SRM will execute site management and provide oversight of site training and quality in accordance with SOPs/processes. This position will also take on additional project management responsibilities as delegated by the Clinical Operations Lead. This position will report into the Project's Director within VBM. It is strongly preferred that the SRM will be based within the Cambridge area to commute to the office on a regular basis. This role requires an individual with demonstrable clinical operations experience and proven expertise in customer service.Main Accountabilities:Conducts Site Visits to orient and train site personnel regarding the protocol, study activities and applicable regulatory requirements.Assures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts.Ensures timely submission of high quality of data from study sites and appropriate query resolutionEnsures safety and protection of study subjects according to the monitoring plan, and applicable SOPs, and ICH GCP Guidelines and/or FDA/local regulations.Proactively works with sites to resolve issues, answer questions, and manage requests for study supplies.Interacts and builds professional and collaborative relationships with all study personnel and personnel in order to facilitate meeting study objectives.Takes on aspects of the project management as delegated by the sponsor, including development of study reports and trackers, quality metrics and risks and mitigations.Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.Proactively communicates and escalates with all internal and external stakeholders issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites including site specific ICFs and essential documents.Uses multiple technologies to foster, maintain, and enhance open communicationTrain, mentor and maintain oversight responsibilities of additional Site Relationship Manager(s) assigned to the studies.Communicates and provides oversight of specified vendors for quality and compliance.Performs on-site visits with specified vendors as applicable.QualificationsEducation:• Minimum of a Bachelor of Science degree in a health related field with clinical research experienceNote: This role is an Internal Clinical Research Associate (CRA). This position requires approximately 50% travel. We can consider candidates who aren't local to Cambridge, but they will be required to be onsite for two or more weeks at the start of assignment for onboarding and to travel to Cambridge frequently for meetings.