Company: INC Research
Location: Poland, Warsaw
Closing Date: 15 Dec 16
Salary (£): Negotiable
Responsible for remote monitoring and site management of Phase II-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. May mentor and/or train less experienced staff.
Responsible for remote monitoring and site management of Phase II-IV clinical research studies while developing mastery and a thorough understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations. May mentor and/or train less experienced staff. Manages and oversees study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures. May be assigned some Lead CRA (LCRA) activities.
•Serves as the primary contact and company representative for sites on assigned studies.
•Manages assigned sites via outbound telephone calls, web-based tools and other communications tools to ensure compliance with the protocol requirements, study procedures and relevant guidelines.
•Creates contact reports for each telephone session (outbound or inbound) with sites.
•Monitors site performance metrics and implements action plans for sites not meeting expectations.
•Supports patient enrollment at each assigned site via engagement of sites in study-wide patient recruitment programs or through development of site-specific enrolment plans.
•Maintains up-to-date information within the deployed Clinical Trial Management System (CTMS).
•Ensures all assigned sites are trained on the study protocol, informed consent process, data collection requirements/data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice/Web Response (IVR/IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patient-reported outcomes instruments, as applicable.
•Maintains timely and effective communication among team members and site staff through oral/written correspondence, and ensures adequate documentation of each communication. Consistently anticipates, identifies, and resolves potential issues, and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
•Assures compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and audits as requested]. Responds to less complex findings without oversight and may require guidance to respond to more complex and/or serious findings. May be responsible for submission of requlatory packages to ethics committees and/or competent authorities.
•Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits.
•Assures timely completion and submission of Electronic Case Reports Forms (eCRFs) in accordance with study-specific clinical and data management plans.
•Reviews eCRFs completed by sites and assists the site in resolving queries and/or other identified data collection issues.
•Assures timely and accurate completion of Data Clarification Forms.
•Performs review of clinical data listings, as required.
Reporting and Tracking
•Completes and submits visit reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions.
•Maintains awareness of key study performance indicators for assigned sites, e.g. Telephone Communications Reports, patient enrolment, and SAEs/Endpoints.
•Updates study and patient status information. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from contact to contact.
•Prepares for and attends Investigator meetings. May present materials, as requested. May attend Customer and Business Development meetings. Assists in the preparation of study start-up materials and tools, as requested.
•Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans. May perform training visits and assessments of less experienced Central Monitoring Associates (CMAs) during the sign-off visits. May assume role as local LCRA and/or assist with LCRA activities, e.g. tool development, study plans, team training and MV report review.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Note: If there are additional responsibilities that are specific to an individual employee, department, country, or other grouping, please use the Job Description Addendum Template.
BA/BS degree in science/health care field or nursing degree, or equivalent combined education and experience, required. Moderate clinical research experience required including at least 1 year of independent remote site management and/or monitoring experience. Thorough understanding of clinical research fundamentals expected. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required. Excellent organizational, documentation, and interpersonal skills essential, as well as a willingness to work within a team-oriented environment. Excellent command of written and spoken local language, if not English, as well as English required. Ability to develop excellent working relationships via oral communication and excellent phone etiquette, required. Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to handle multiple tasks to meet deadlines in a dynamic environment, required.
INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
|Tel:||+36 1 489 48 56|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.