Clinical Nurse Reviewer, Specialty Solutions

Primary Responsibilities
Identifies project guidelines and communication needs by:
Reviewing study requirements and endpoint definitions and collaborates with key stakeholders to develop study start-up activities and associated documents for endpoint adjudication
Assists the Clinical Endpoint Project Manager in the development of the quality control and query process for endpoint adjudication
Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)
Works independently across multiple trials performing a quality control of endpoint dossiers
Assists with site and CRA training for CEC dossier submission and query resolution
Performs project analysis and management by:
Works on complex detailed projects that require in depth analysis and understanding
Identifying critical project success factors for tracking, analysis and reporting
Communicates needed resources for project completion to Manager, CPM
Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
Understanding SOPs and working closely with QA for clarification and documentation of deviations
Training and maintaining project team knowledge and applications of SOPs
Assists in creation of SOP and WP specifically related to endpoint adjudication
Assist the Project Manager with site management of data collection with internal and external teams
Coordinating selection and management of the Endpoint Adjudication committee members
Assist the Project Manager with project/ system training to committee members
Provides project team leadership in managing project load and allocates work to APM’s by:
Leading by example with professional and collaborative conduct
Developing and delivering team project training
Reinforcing team performance expectations and guidelines
Providing input to departmental managers of respective team members’ performance level
Providing feedback to Manager, CPM on team performance for consistency/quality within established project guidelines
Collaborating with the departmental managers for team coaching/mentoring
Supports Business Development efforts by:
Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
Attending professional meeting(s) as Company representative
Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services
Oversees project close out by:
Assisting with coordination of submission activities, as applicable
Assisting with initiating and overseeing all project close out activities to completion
Performs supervisory functions by, if applicable:
Communicating job expectations to APM’s
Participating in new hire interviews; provide feedback as directed
Training new hires on departmental processes and responsibilities
Maintains Quality Service and Departmental Standards by:
Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
Establishing and enforcing departmental standards
Reviewing and updating company SOPs related
Secondary Responsibilities
Maintain quality service and departmental standards by:
Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
Assisting in establishing and enforcing departmental standards
Contribute to team effort by:
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
Maintain technical and industry knowledge by:
Attending and participating in applicable company-sponsored training

• Reviewing study requirements and endpoint definitions and collaborates with key stakeholders to develop study start-up activities and associated documents for endpoint adjudication
• Assists the Clinical Endpoint Project Manager in the development of the quality control and query process for endpoint adjudication
• Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)
• Works independently across multiple trials performing a quality control of endpoint dossiers
• Assists with site and CRA training for CEC dossier submission and query resolution

• Works on complex detailed projects that require in depth analysis and understanding
• Identifying critical project success factors for tracking, analysis and reporting
• Communicates needed resources for project completion to Manager, CPM
• Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
• Understanding SOPs and working closely with QA for clarification and documentation of deviations
• Training and maintaining project team knowledge and applications of SOPs
• Assists in creation of SOP and WP specifically related to endpoint adjudication
• Assist the Project Manager with site management of data collection with internal and external teams
• Coordinating selection and management of the Endpoint Adjudication committee members
• Assist the Project Manager with project/ system training to committee members

• Leading by example with professional and collaborative conduct
• Developing and delivering team project training
• Reinforcing team performance expectations and guidelines
• Providing input to departmental managers of respective team members’ performance level
• Providing feedback to Manager, CPM on team performance for consistency/quality within established project guidelines
• Collaborating with the departmental managers for team coaching/mentoring

• Collaborating with BD Director in the development and presentation of company capabilities calls/meetings

• Attending professional meeting(s) as Company representative
• Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services

• Assisting with coordination of submission activities, as applicable
• Assisting with initiating and overseeing all project close out activities to completion

• Communicating job expectations to APM’s

• Participating in new hire interviews; provide feedback as directed
• Training new hires on departmental processes and responsibilities

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)

• Establishing and enforcing departmental standards

• Reviewing and updating company SOPs related

• Reading, understanding, and adhering to organizational standard operating procedures (SOPs)

• Assisting in establishing and enforcing departmental standards

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

• Attending and participating in applicable company-sponsored training

• Licensed nursing professional

• Previous management or project experience in clinical development of investigational medications required
• 2 years clinical experience
• 2-3 years clinical experience within a CRO or pharmaceutical research organization required
• Working knowledge of GCH, ICH guidelines and FDA regulations
• Clinical Endpoint /Adjudication experience

• Experience working with computer software including Word, Excel, Access and Project preferred

• Strong motivational skills and abilities, promoting a team-based approach
• Works independently with little to no supervision or oversight, required
• Ability to multi task
• Ability to delegate power and authority to a person acting as a representative
• Strong client management to minimize non-standard sponsor requests and escalations
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain professional and positive attitude