Requisition ID 14690BR
Title Senior In-House CRA
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical, Medical & Regulatory Affairs (CMR). Responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk (NNI) SOPs.
RELATIONSHIPS:
Reports to a Manager/Associate Director of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
ESSENTIAL FUNCTIONS:
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.
PROJECT SUPPORT:
- Accountable for the set-up, quality and maintenance of the electronic Trial Master Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide develop regulatory documentation to support study start up activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA to resolve site related issues.
- Arranges for certified translation of study documentation as appropriate.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
- Attends Investigator Meetings and study-specific training for assigned trials
- Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and/or CRAs as appropriate.
- Completes follow up letters from all visit types according to SOPs and complete reports to quality standards within company specified timelines.
- Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
- Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc) and responsible for the follow up to collect outstanding documents.
- Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
- Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
- Responsible for the submission and correction of regulatory green light packages to the Quality Management Group within CTM for approval.
- Responsible to coordinate and secure IRB approval (local and central). Responsible to provide step by step guidance and partnership with sites to secure IRB approval.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.
PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to visit assigned sites for monitoring and/or trainings as required
- Office Based in Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- A Bachelors’ degree (science-related discipline preferred).
- At least a minimum of 6 years of clinical trial experience within pharmaceutical, biotechnology or CRO company and/or healthcare setting.
- A minimum of 12 months of site monitoring experience required.
- Direct expertise of site management and logistical execution of clinical trials for 3 years.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (1c)
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%
Title Senior In-House CRA
Job Category Clinical
Job Description PURPOSE:
Responsible for the support of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical, Medical & Regulatory Affairs (CMR). Responsible for monitoring assigned sites in accordance with GCP/ICH and Novo Nordisk (NNI) SOPs.
RELATIONSHIPS:
Reports to a Manager/Associate Director of Site Management (SM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.
ESSENTIAL FUNCTIONS:
COORDINATION / COMMUNICATION, ADMINISTRATION AND PERSONNEL DEVELOPMENT:
Ensure compliance with the application and communication of all Novo Nordisk® policies, procedures and fundamentals.
FUNCTIONAL SUPPORT:
May participate in continuous improvement processes for function.
PROJECT SUPPORT:
- Accountable for the set-up, quality and maintenance of the electronic Trial Master Files (TMF) in accordance with NNI SOPs. Performs ongoing reviews of TMF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines.
- Accountable to provide develop regulatory documentation to support study start up activities, including all site supplies.
- Act as primary liaison for assigned study sites to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues.
- Act as primary liaison for assigned study sites while on-site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA to resolve site related issues.
- Arranges for certified translation of study documentation as appropriate.
- Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA.
- Attends Investigator Meetings and study-specific training for assigned trials
- Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate.
- Collaborates with the Lead CRA(s) to obtain/share trial specifics issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) and/or CRAs as appropriate.
- Completes follow up letters from all visit types according to SOPs and complete reports to quality standards within company specified timelines.
- Completes Site Selection, Site Initiation, Routine Monitoring and Close-out Visits according to SOPs and completes reports to quality standards within company specified timelines.
- Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites.
- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned CRA.
- Liaises with Clinical Budget Management to secure confidentiality agreements, master services agreements, clinical trial agreements as appropriate. Uses this information to prioritize sites for Greenlight approval.
- Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites.
- Performs on-site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements.
- Preparation and review of various study related tracking systems to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB etc) and responsible for the follow up to collect outstanding documents.
- Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
- Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site.
- Responsible for the submission and correction of regulatory green light packages to the Quality Management Group within CTM for approval.
- Responsible to coordinate and secure IRB approval (local and central). Responsible to provide step by step guidance and partnership with sites to secure IRB approval.
- Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
STAFF DEVELOPMENT:
- May provide active mentorship of CTM staff to build talent across the department.
- May support in the identification of training gaps, may support the development of training materials to meet that gap and then provision of training as required to improve core competency and skill set of the department.
- May support the maintenance of guidelines, training programs, policies and procedures.
TEAM COORDINATION:
- Accountable for the compliance and quality of CATS reporting.
- Active membership to local project teams.
- Participates in cross-functional teams, locally, to assure timely attainment of project milestones.
- Responsible to conduct oneself in accordance with expectations as a project team member to ensure the success of a matrix management structure.
- Responsible to ensure that the mandatory trial entries are made in IMPACT, NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- Provide support of training needs across CTM and may support the creation, development and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members and/or CTM.
PHYSICAL REQUIREMENTS:
- Approximately 50% overnight travel to visit assigned sites for monitoring and/or trainings as required
- Office Based in Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- A Bachelors’ degree (science-related discipline preferred).
- At least a minimum of 6 years of clinical trial experience within pharmaceutical, biotechnology or CRO company and/or healthcare setting.
- A minimum of 12 months of site monitoring experience required.
- Direct expertise of site management and logistical execution of clinical trials for 3 years.
- Demonstrated computer skills (MS Office, MS Project, PowerPoint).
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
- Knowledge of GCP as relates to clinical trial management.
Department CMR - SITE MANAGEMENT (1c)
Position Location US - Princeton, NJ
City PRINCETON
State/Provinces US - NJ
Degree Required Bachelor's Degree Required
Percent Travel 30 - 40%