US:

Director of Clinical Monitoring, In-house CRAs, field

CRAs, EU:

Associate Director of Clinical Monitoring, CRAs, CTCs and Clinical Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description

KEY RESPONSABILITIES

Provides guidance, oversight, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Ensures quality of data is in line with clinical standards and that the rights and safety of patients involved in studies are protected. Monitors performance of CRAs on a continuous basis, including reviewing monitoring visit reports and conducting co-monitoring visits as needed. Performs CRA mentoring and oversight of CRA activities including evaluation of quality of work through co-monitoring. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Clinical Monitoring Plans and training presentations as needed. Assists in resourcing CRAs for planned and ongoing clinical trials. Supports CRA hiring through initial screening, phone, and video interviews of potential new employees. Responsible for CRA new hire training and onboarding. Conducts review of CRA time and expenses, as appropriate. Provides monthly billing information to finance team. Performs qualification, initiation, interim, and close-out visits both onsite and remote, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Conducts investigational product accountability. Reviews site regulatory binder for required documents, performing quality assurance of documents collected at sites for uploading to eTMF/TMF. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Proactively identifies site issues and develops problem-solving strategies. Conducts audit preparation at study sites as needed. Supports study team with set-up, collection of site specific ethics documents and site contract negotiation as required. Participates and attends bid defense meetings as required. Supports improvement and set up of new company processes/procedures related to monitoring activities. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Promote a collaborative team atmosphere between CRAs. Participates in internal, client/sponsor, scientific, and other meetings as required Performs additional duties as assigned.

DESIRED QUALIFICATION & EXPERIENCE US

BS/BA from an undergraduate program (life sciences or related discipline preferred)

US:

4 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 years' experience in clinical monitoring with 1 year of management experience EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.

EU:

Graduation in a scientific/health field

EU:

Extensive experience in clinical monitoring, in local and international studies, multiple therapeutical areas and phases. Experience in clinical project management is not mandatory but is considered as a plus Excellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulations

Compensation:

USD $110,000 - 130,000 commensurate with experience

TECHNICAL COMPETENCES & SOFT SKILLS

Proven ability to be careful, thorough, detail-oriented and quality focused Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to problem-solve unstructured or ambiguous challenges

US:

Strong command of English, both written and verbal Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use CTMS systems, clinical trial databases and electronic data capture Knowledge of Pharmacovigilance processes Ability to travel Professional, trustworthy and disciplined Able to manage stress and conflicts Leadership attitude Problem solving skills Self-starter who thrives in a collaborative, yet less structured team environment

US:

Permanent authorization to work in the U.S.

EU:

Adequate English

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs. Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy Contract Type Regular Salary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate's confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

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Lead Clinical Research Associate