Site Management Specialist II Outcome Software, Inc.
THIS JOB HAS EXPIRED Function: Clinical & Data Management
Department: Site & Patient Services
Country/Location: Americas, Asia Pacific
Manager, Site & Patient Services (SPS)
Liaises with study sites and patients from study start-up to study close-out as specified in the project management plan, maintains relationships with investigators (in bound and out bound calls), coordinate activities with CRA as applicable, interact with the sponsor, patients and the internal Quintiles project team as need. Commonly performs the following activities:, study start-up document review and tracking, site status tracking and updating, CRF creation, remote site initiation and support, centralized monitoring and management, site support, and clinical study data processing. Provides accurate, timely, and consistent study information to both sponsors and other internal departments to support the business needs of Quintiles. Accountable for delivering monitoring reports and other study activities led by SPS on time and within budget.
Prioritize, resolve, and/or disseminate inquiries and requests from Quintiles project team members, client, and sites.
Acts as site liaison to develop and maintain rapport with study site personnel, vendors, sponsors and Quintiles team members.
Assists with the development of materials for and performs regulatory document collection and tracking (where applicable), technical support, pre-study, study initiation, monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Plans.
Performs in-house site support activities, researching and responding to various site inquiries (study materials, protocol, systems use, study documents, CRF conventions, queries, payments, etc.), appropriately tracking and documenting these interactions.
Assists in the development of and maintains study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters and telephone scripts
Participates in the preparation and coordination of investigator meetings or other investigator site training and attends investigator meetings as requested.
Performs quality control (QC) activities across all areas of project responsibilities.
Adheres to safety reporting requirements
Adheres to a schedule of project-related communications (e.g., calls, mailings, reports) and activities and effectively employs technology for tracking.
Attends and presents SPS status at project team and client meetings as requested
Establishes working relationships with other Quintiles personnel to ensure that study-specific documentation is retrieved, filed and maintained in a high quality, timely quality manner.
Anticipates/identifies potential problems and implements corrective actions. Suggests and implements alternative solutions to problems with study timelines, schedules, resources, etc. to department or study management.
Performs the following data management activities: direct data entry from telephone interviews, CRF routing, data reviewing, querying, and updating.
Assists in the development of patient enrollment strategies
Manages telephone calls and e-mails generated by recruiting and advertising initiatives from the general public, potential patients, their families, or referring physicians and provides approved study information
Provides support for study awareness, patient recruitment, and investigative site activities, including manning toll-free public call center and investigative site help lines. Serves as a central contact point for public inquiries regarding studies.
Conducts outbound telephone calls per project requirements, including administration of patient assessment tools (e.g., Quality of Life (QoL) questionnaires, patient compliance surveys) and acquisition of study documents (regulatory documents, queries, etc.) and general site management.
May be asked to travel to study sites in support of on-site monitoring activities
Prepares and distributes regular status reports
When requested, provides support by assisting with limited monitoring activities on site
Continues professional development in a manner that ensures increased industry knowledge.
Executes other duties and assignments as requested for the overall performance of the department and the company.
Education: AA/AS degree or equivalent a life sciences discipline is highly desired
Experience: At least 2 years of related industry experience. Previous practical experience with clinical research studies in a CRO, site setting, or pharmaceutical company preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Additional skills: Necessary attributes include: Strong organizational and leadership skills, excellent oral/written communication skills, proficiency with computer/software systems, ability to prioritize a diverse workload, and attention to detail with a focus on quality. Strong interpersonal, telephone communication and customer service skills and ability to work on a team or independently as needed. Familiarity with medical terminology a strong plus.
Primary Location: USA-Massachusetts-Cambridge
Organization: USA02 - US Clinical Development Svcs
||Cambridge, MA |
THIS JOB HAS EXPIRED