JOB SUMMARY  

The Central Monitor (CM I) will perform remote patient data review activities for Phase I-IV clinical research and/or non-interventional studies (NIS) to assess compliance with the protocol, ICH-GCP, and/or all applicable local and federal regulatory requirements as well as ensure patient safety and data integrity using a variety of technologies.  Requires guidance and oversight, while developing an understanding of the drug development and commercialization process

JOB RESPONSIBILITIES

• Reviews and understands protocol, critical data and process, safety, and data integrity risks related to protocol execution.

• Reviews patient data listings and visualizations via analytical dashboards and/or reports to confirm eligibility, identify protocol deviations, patient safety concerns, data integrity issues and illogical/inaccurate/missing data.

• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

• Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.

• Reviews action resolutions raised by CM and completed by CRAs and confirms that they adequately and completely resolve the issues raised.

• Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for action by sites, CRAs or other functional team members.

• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

• Accesses vendor systems or reports to verify the IP has been dispensed and administered to subjects/patients according to the protocol, that laboratory and other procedures have been performed, that eTMF data is current and complete.

• Documents completion of activities via tracking, reporting and/or other required project documents as per SOPs and Monitoring Plan.

• For assigned activities, understands CM project scope, budgeted hours, and timelines; manages patient- and site-level activities assigned to CM in the clinical or central monitoring plans to ensure project objectives, deliverables and timelines are met.

• Must be able to quickly adapt, with the oversight of the Lead CRA/Central Monitoring Lead (CML), to changing priorities to achieve goals/targets. 

• Prepares for and attends Investigator Meetings and/or sponsor meetings. Participates in project staff meetings as applicable and attends clinical training sessions according to the project specific requirements.

   

QUALIFICATION REQUIREMENTS

·       Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.

·       Knowledge of Good Clinical Practice/ICH E6 (R2) Guidelines and/or other applicable regulatory requirements.

·       Must demonstrate good computer skills and be able to embrace new technologies

·       Mastery of MS Excel preferred (sorting, filtering, calculating, pivoting)

·       Excellent verbal and written communication skills to relate to internal stakeholders.   

·       Strong analytical skills

·       <10% travel (limited to trainings, investigator meetings)

·        Language skills: English - high level

Any additional language is a strong plus: Polish, Hungarian, Hebrew, Spanish - native or high level

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.  Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Equal Opportunities Plan. Its objective is to achieve the principle of equality of opportunity in Syneos Health’s employment practices ensuring that our workforce is truly representative of each gender and that every employee is respected and is able to work under equal conditions.