• Communication with the Client is multi-faceted
• Focus on the quality of existing projects with the Client while also assessing new business opportunities with the Client
• Work together with business development in the initial communication with the Client on the project scope of work, timelines, contract, budgets, and staffing
• Facilitate staffing of project, including screening of staff, scheduling interviews and ongoing quality management of assigned staff
• Ongoing and regular communications with the Client to assess the progress of the project(s), the Client’s satisfaction with the work performed and address any outstanding issues or escalated issues
• Ongoing communication with the Client regarding changes in the scope of work, timelines and resourcing. 
• Communicate the impact of any changes on the budget, contract and staff assignments and implement any associated changes
• Provide budget reports (i.e. monthly, quarterly), which may include projections, estimates and/or actuals
• Attend project meetings when a Client Manager presence is necessary
• Arrange a face to face meetings with the Client, at minimum semi-annually

Skills: Client Relationship Management, Project Coordination, Budget Oversight, Contract Management, Team Leadership, Quality Assurance, Strategic Communication, Meeting Coordination

• Maintain frequent communication and high visibility (as available) within the client organization
• Assess business expansion opportunities within existing programs and/or client
• Seek introductions and opportunities within other programs
• Receive and review RFPs, formulate strategy, develop proposal and budget, prepare for and present at Bid Defense meetings
• Ongoing frequent communication with the ProTrials Clinical Project Manager and ProTrials Management regarding changes in the scope of work, project goals, timelines, staff assignments
• Work closely with the Director of Business Development to streamline communication with the Client (if the Client was in contact with the BD team)
• Work closely with the ProTrials Project Manager or other assigned staff to:
• Assure that the study progress is on target
• Identify, escalate and address any major project issues
• Identify and address any team training issues
• Review resource utilization monthly

Skills: Client Engagement, Business Expansion, Proposal Development, Project Coordination, Communication Management, Performance Monitoring, Issue Resolution, Resource Review

• Supervises collection of study specimens, their processing, storage and shipping.
• Works with investigators to develop and write protocols for clinical trials and prepare supporting documents for grand and IRB approval. 
• Maintains study equipment logs and calibration.
• Conducts site monitor visits and site regulatory audits.
• Acts as Ophthalmic Technician when directed, based upon needs of the clinic.
• Ensuring time and attendance procedures are followed in the department and ensuring PTO requests are responded to in a timely manner and updated in the timekeeping system as well as ensuring time cards of the team are correct and submitted by deadlines
• Assist in and/or are responsible for mentoring and training assigned team members whose performance is below clinic standards and expectations.
• Effectively working with other teams, both administrative and clinical to ensure clinical research studies and projects run smoothly.
• Contribute to and/or perform audits and evaluations, coordinating with Director and/or Managers in Patient Care Operations area as applicable
• Supporting training, including but not limited to, new hire training, internal transitioning, mentoring current staff, and providing skills assessments.
• Assist in resolution of patient concerns and complaints as applicable
• Serve as a representative for the Clinical Research department as directed.
• Efficiently juggle supervisory and other work responsibilities
• Deliver superior service to physicians, employees, and patients.

Skills: Specimen Management, Protocol Development, Audit Compliance, Clinical Assistance, Timekeeping Oversight, Staff Training, Patient Relations, Service Excellence

• Overseeing the execution of clinical trials, from protocol development to final analysis and reporting
• Communicating objectives and timelines clearly with internal stakeholders and external clinical partners
• Monitoring each study to ensure that it complies with protocols, is ethically conducted, and follows regulatory standards
• Maintaining research records of study activities using clinical research software
• Coordinating the implementation of clinical studies by training on-site study staff to administer study materials and devices
• Communicating progress and issues to study investigators, relevant institutional review boards, and internal stakeholders
• Supervising clinical study project managers and/or research assistants
• Communicate any Client or ProTrials decisions that may impact the project
• Coach ProTrials Project Manager or other assigned staff 
• Assisting with the development of study tools, consultation on strategy, consultation on team/client/vendor/site interactions, and assistance with general problem-solving
• Attend occasional project team teleconferences, Kick-Off Meetings, Investigator Meetings and other meetings when a Client Manager presence is appropriate
• Complete performance evaluation surveys of project team members

Skills: Clinical Trial Oversight, Stakeholder Communication, Regulatory Compliance, Data Management, Study Coordination, Team Supervision, Strategic Consulting, Performance Assessment

• Responsible for planning, initiating, monitoring, tracking and/or prioritizing clinical research projects and process improvement initiatives 
• Facilitating successful, on-time and within budget execution.
• Sets clear direction and management that aligns with defined practices and policies and enhances the organization's clinical objectives.
• Interacts and works closely with other departments, including but not limited to Clinical, Quality, Medical Safety and Medical Affairs and Regulatory Affairs 
• Ensure program execution to achieve business goals within regulatory requirements.
• Manages day to day activities for multiple work-stream teams through managing project plans, resourcing, status reporting, resolving issues
• Identifying project risks and accountability for deliverables across multiple functional organizations.
• Establishes meaningful metrics.
• Responsible for project performance, risk management, administration, financial management, budgeting and issue resolution.

Skills: Project Management, Budget Oversight, Cross-Department Coordination, Regulatory Compliance, Risk Management, Performance Metrics, Resource Allocation, Process Improvement

• Experience in biotech, pharmaceuticals or a related field
• People management experience training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials
• Therapeutic or medical knowledge
• Understanding of all aspects of monitoring and trial execution
• Excellent site management capabilities with demonstrated capability to problem solve and mediate complex compliance issues
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (CNDA), local/National Health Authorities regulations
• Excellent multi-tasking skills and proven ability to work under pressure.
• Excellent verbal and written communication skills.

Qualifications: BS in Biology with 5 years of Experience

• Knowledge of federal and local regulations and policies pertinent to research involving human subjects
• Experience in the design, conduct and analysis of clinical trials and epidemiologic studies
• Prior experience in a clinical research environment
• Knowledge of biomedical sciences and clinical research
• Familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case-control, and case-series designs
• Basic knowledge of microbiology and infectious disease epidemiology
• Knowledge of PCs including MS Word, Excel, and PowerPoint, ability to write clearly and concisely
• Excellent communication and interpersonal skills
• Ability to establish goals and agendas.

Qualifications: BS in Biochemistry with 4 years of Experience

• Knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirements 
• Demonstrated ability to organize and present scientific information (e.g., clinical study results) to internal and external audiences 
• Excellent verbal and written communication skills.
• Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills.
• Good command of written and spoken English language Plans and makes decisions by considering impact from all relevant perspectives
• Able to verbalize decisions in a thorough and effective manner 
• Able to proactively identify and address areas of inefficiency and provide creative, successful solutions.
• Holds self and others accountable for adherence to high work and ethical standards Flexible, adapts work style to meet department and company needs 
• Develops solutions based on limited information and oversight.
• Experience with protocol writing and case report form design.

Qualifications: BS in Biomedical Science with 6 years of Experience

• Experience in early clinical development, with emphasis on Clinical Study Management, supported by previously gained experience in clinical study monitoring
• Fluent in written and spoken English
• Knowledge of Good Clinical Practice and ICH Guidelines is a must
• Knowledge and Early Development, Phase I and Phase II environment is a must
• Knowledge of Immunology (scientific knowledge) is an asset
• Experience working in a matrix-structured organization is an asset
• Good Project Management Skills
• Solid scientific reasoning and good presentation skills
• Excellent Communication Skills
• Good knowledge of Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
• Ability to manage several studies simultaneously and to identify priorities
• Ability to advise, persuade and negotiate with colleagues in a supportive and constructive fashion
• Excellent decision-making skills

Qualifications: BS in Clinical Research with 7 years of Experience

• Clinical trial management experience within medical devices.
• Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) certification required
• Hospital environment experience
• Experience in preclinical research
• Knowledge of FDA regulations and their practical implementation.
• Ability to work with healthcare professionals, researchers, administrators, and study teams.
• Experience with statistics or statistical models for clinical studies is strongly preferred
• Demonstrated interpersonal communication skills with the ability to communicate across functional areas
• Excellent analytical and writing skills
• Strong project management skills, ability to juggle multiple competing priorities
• Solid project management or people management experience

Qualifications: BS in Nursing with 5 years of Experience