Senior Clinical Project Coordinator (Contract, Home-Based) - NCR
Provides project related support to the ProjectManagement staff and other project team members from the proposal developmentthrough final deliverable. To provide strategic leadership, organization,training, and ongoing support to the project coordination group which includesSenior Project Coordinators, Project Coordinators, and Project Assistants
ESSENTIAL JOB FUNCTIONS,DUTIES AND RESPONSIBILITIES:
- Supportsthe Sr. Manager, Project Coordination/ Manager, Project Support &Coordination in the management of the Project Coordinators and Project Assistantsin the implementation of tasks and responsibilities within their jobdescription.
- Interviewpotential project coordination team candidates. Provides recommendations to the Sr. Manager, Project Coordination/Manager, Project Support & Coordination regarding the hiring of potentialcandidates.
- Mentorsand trains new in-house and remote employees in the implementation of tasks andresponsibilities within their job description.
- Occasionallymay be asked to present information or training on topics applicable to theProject Coordination team during monthly Project Coordination team meetings.
- Responsiblefor the tracking, measurement, and evaluation of project metrics to implementefficiencies. Suggests recommendationsfor outliers found in output.
- Worksin conjunction with Project Manager to formulate and maintain a projectspecific training matrix. Communicateswith training department to ensure matrix is uploaded into LMS.
- Drivesthe development, printing, shipping, and tracking of study binders.
- Responsiblefor coding project specific invoices and submitting for approval
- Responsiblefor printing and forwarding project master file documents to the NovellaClinical Central File Room to ensure theproject master file is current,complete, and audit ready. For those projects utilizing an electronic projectmaster file, responsible for emailing project master file documents to theappropriate inbox. Assists ProjectManager with project master file audits and formulates recommendations formissing components.
- Collaboratesin the design, development, and maintenance of CTMS.
§ Participatesin user acceptance testing (UAT).
§ UpdatesCTMS operations guide with project specific information.
§ Suggestssystem enhancements to development team.
- Perproject requirements, manages protocol deviation tracking, including clientevaluation and subsequent documentation. Formulates recommendations to createefficiencies.
- Perproject requirements, develops methodology for site training documentation andinterfaces with client.
- Perproject requirements, develops project specific working practices.
- Perproject requirements, oversees and delegates project specific tasks to thoseProject Coordinators allocated to the trial.
- Maintainssupport responsibility, including scheduling, managing agenda updates, andmeeting minutes for project teammeetings and other meetings, as assigned.
- Providesproject administrative supportincluding meeting minute documentation, monthly reports,shipping, filing, tracking, and status summarization, as appropriate
- Participateand assist in the planning and creation of client and investigator meetings andrelated materials
- Performother duties, as required.
KNOWLEDGE, SKILLS ANDABILITIES:
- Adequateknowledge of the clinical research process
- Excellentwritten and verbal communication skills
- Excellentorganizational and time management skill
- Experiencein a team/matrix environment
- Demonstratedability to form strong functional relationships, maintain a positive attitude,and ability to interact with all levels of staff to coordinate and executestudy activities
- Abilityto handle multiple priorities within multiple clinical trials
- Extensiveexperience with Microsoft Office
CRITICAL JOB FUNCTIONSIN ACCORDANCE WITH ADA CRITERIA:
- Verylittle physical effort required to perform normal job duties
- Abilityto travel nationally and internationally, as required
- AA/BA/BSdegree preferred and/or
- Minimumof two (2) years of related experience in a clinical trial setting is required
- Extensiveknowledge with Microsoft Office
- Priorexperience with mentoring/training of staff is preferred
- Abilityand willingness to travel nationally and internationally as required
- Excellentverbal and written communication skills required
- Excellentinterpersonal and organizational skills required
- Abilityto work independently, prioritize and work in a matrix team environmentrequired
- Computerliteracy required
EEO Minorities/Females/Protected Veterans/Disabled
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