POSITION SUMMARY:
Unique opportunity for a qualified, experienced, and self-motivated Clinical Trials Data Coordinator/ Clinical Research Coordinator or Research Nurse to work in Wurzburg, Germany as a Clinical Data Coordinator to abstract data, complete case report forms (CRFs), for an innovative anti-viral treatment.
Position Type: Contractor/freelance position
Position Reports to : German PI or designee (note all actions involving patients or data will be carried out under the direct supervision of the site PI or delegate.
Duration of Contract: 12 weeks
Work Hours: 20 hours per week
Location: Onsite, Würzburg, Germany
Start Date: ASAP
Clinical Trial Data Coordinators are responsible for:
* Maintaining the data integrity of an assigned research study
* Abstracting data, completing case report forms (CRFS), and answering queries.
* Meet with sponsor representative during monitor visits and maintain data in an audit-ready state, meeting the contract’s requirements.
* Maintain the research record and patient information ) the appropriate site system(s).
Eligible candidates will be:
* Well-versed in Good Clinical Practices (GCP) as defined by the International Council for Harmonization (ICH E6), applicable European Union regulations, German national laws and regulations, and requirements of the Ethics Committees, as well as data protection requirements under the General Data Protection Regulation (GDPR). Able to work as a clinical research team member with positive and timely written and verbal communication, including sharing information. This includes communicating protocol deviations or issues with study execution.
* Seek supervision appropriately, prioritize appropriately, complete work promptly, and demonstrate accuracy in all details.
ESSENTIAL JOB FUNCTIONS:
Data Management & Protocol Compliance (80%)
* Ensures all protocol procedures are completed as specified in the protocol.
* If made aware of any adverse events (AEs), ensure they are promptly reported to the sponsor, study team, and institution in accordance with the protocol and applicable regulatory requirements.
* Abstracts data from the medical record and completes electronic CRFs, including responding to any requests for data clarification.
* Ensures data accuracy with source documentation.
* Ensures documentation processes are followed according to GCP.
* Maintains all necessary patient source documents for assigned studies.
* Obtains data from outside facilities, including images, specimens, and medical records, as needed. Ensures PHI is only accessed under the authority of the site and in compliance with GDPR. certification.
* Responds to all requests for data clarifications of assigned study
* Meets contractual or institutional requirements for timeliness of data entry and query resolution.
* Fulfills sponsor requirements related to reportable information, including AE, unanticipated problems, and other information required by the sponsor protocol.
Administration (13%)
* Participates in required teleconferences, study meetings, both on and off-site, as required.
* Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
* Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
* Reviews monitoring reports for assigned studies, determines any discrepancies, and resolves outstanding data issues identified by the monitor.
* Participates in audits and monitor visits for assigned studies, as requested.
* Identifies and promptly communicates necessary protocol and data management issues or problems to the PI and supervisor.
* Other related duties as assigned or requested. (5%)
* Participate in study team meetings.
* Participate in staff meetings.
* Identifies and participates in professional development activities and opportunities.
* Serve as a resource to other staff regarding assigned protocols.
Other duties as assigned.
* Job descriptions are not intended and should not be construed to be exhaustive lists of all responsibilities, skills, efforts, or working conditions associated with a job.
* Follows established research institution and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
* Performs other related duties as assigned or requested.
SKILLS & ABILITIES:
* Excellent skills in time management, prioritization, and multi-tasking are required. Strong organizational skills, Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and ability to interact effectively with co-workers and customers. Strong attention to detail. The ability to focus on a task is essential.
* Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects daily.
* Strong command of the English and German languages, including spelling, writing, and verbalizing, and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality.
* Access data in computer databases
* Compile data
* Proofread documents.
* Research information
* Troubleshoot problems.
* REQUIREMENTS:
* Bachelor’s Degree, relevant experience may substitute for a degree.
* At least two years of experience as a Clinical Data Coordinator, Research Nurse or Clinical Research Coordinator for industry-funded clinical trials.
* Working knowledge of clinical trials, "Applicable European Union Regulations, German national laws and regulations, and requirements of the Ethics Committees.
* Certificate of completion for Good Clinical Practices (GCP)/International Conference on Harmonization (ICH) training
* Certificate or evidence of data protection training.
* Microsoft products, including but not limited to word-processing software, internet, and general computer proficiency required.
* Fluent in German and English
* Experience with Infectious Disease trials, a plus.
* Familiarity with ClinTrak EDC, a plus.
* Experience with SAP’s EHR, a plus.