Senior Clinical Research Associate (Fixed Term) - 1015

A Senior Clinical Research Associate (Sr. CRA) is responsible for:

• Conducting monitoring activities at assigned clinical trial site(s)
• Verifying the adequacy, reliability, and quality of data collected at clinical sites
• Ensuring the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with applicable regulatory requirements in the assigned countries
• Subject safety, data integrity, and protecting the subject confidentiality
• Mentoring CRAs and other Clinical Operations (CO) staff
• Anticipating, recognizing and resolving issues in the served study sites and may oversee such activities of CRA/other CO staff

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Follows and ensures assigned studies are conducted in compliance with the currently approved Protocol(s)/Amendment(s), Standard Operating Procedures (Advanced Clinical or Sponsor SOPs), Code of Federal Regulations (CFR), Good Clinical Practice (ICH GCP), and local or country regulations
• Participates in Investigator feasibility and selection process by contacting sites to obtain feasibility information
• Conducts site qualification (pre-study), site initiation, routine interim and close-monitoring visits for assigned studies and sites
• Travels to research sites to conduct on-site visits as required
• Prepares site submissions to the Independent Ethics Committees (central and local) and to Competent/Regulatory Authorities, when applicable
• Assists with the development of Investigator and Institution contracts and budget templates, negotiates site budgets, and arranges site payments, when applicable
• Attends internal CRA Team meetings and participates in study team and sponsor meetings, as required
• Participates in Investigator meetings and assists with meeting preparation, when required
• Conducts monitoring visits per the monitoring visit frequency defined in the Monitoring Plan or as instructed by the study team and confirms visit attendance by sending visit confirmation letters to site staff
• Manages his/her own monitoring visit schedule for all assigned sites in accordance to the Monitoring Plan or the study needs
• Proactively schedules appointments to meet with site staff during monitoring visits
• Verifies that all delegated study staff at assigned sites are trained/certified and maintain compliance with requirements of the study protocol, informed consent process, data collection requirements, Investigational Product/Investigational Medical Device (IP/IMP) accountability/supply management, and safety reporting requirements
• Ensures the adequacy, reliability, and quality of all study data at assigned sites by performing source data review, source document verification, query resolution, and regulatory document and investigational product review
• Ensures that each assigned site is equipped with all necessary study equipment and supplies, and that the procedures (including sampling, processing, storage and shipment logistics) are appropriately adhered to
• Ensures subject safety, data integrity, and subject confidentiality
• Writes monitoring visit reports (MVRs) and sends site visit follow-up letters (FUL) as outlined in SOPs and study Monitoring Plans
• Routinely reviews the Investigator Site File (ISF) and the Pharmacy Binder (if applicable) for accuracy, timeliness and completeness
• Reconciles the Investigator Site File (ISF) with the Trial Master File (TMF) and uploads any documents obtained during monitoring visits to the TMF to ensure inspection readiness at all times
• Maintains awareness of key study performance indicators via regular communication with the site and clinical study team including Investigators, study coordinators, pharmacist, and other study personnel
• Discusses study status, timelines, patient recruitment, screening, enrollment, and retention efforts, ongoing patient status, IP/IMP supplies, study supplies, and any further requests or issues with each assigned site
• Conducts routine follow-up of open action items between monitoring visits to ensure timely closure
• Creates and maintains study/site trackers to successfully conduct monitoring visits
• Provides project specific training, mentoring, and/or co-monitoring with new CRAs.
• Completes assigned function area and study specific trainings
• Performs other duties as assigned per Advanced Clinical needs

QUALIFICATIONS:

• Must have 3-5 years of clinical monitoring experience
• The ideal candidate should have a Bachelor's degree in life sciences, a nursing degree, or be able to demonstrate equivalent experience
• Ability to travel up to an average of 80%, depending on project needs
• Must demonstrate clear understanding of the drug development process, clinical monitoring, and safety and regulatory requirements
• Must have excellent verbal and written communications skills as well as excellent interpersonal, presentation, and organizational skills with demonstrated attention to detail
• Must be able to work independently and in a team environment
• Must be computer literate with proficiency in MS Office including Outlook, Word, Excel, and PowerPoint as a minimum
• This role may be office and/or home-based however regular infrequent visits to a Company office will also be required.