Requisition ID 18232BR
Title Clinical Trial Coordinator
Job Category Clinical
Job Description PURPOSE:
Responsible for the administrative support to study team and maintenance of key information in various systems in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM).
RELATIONSHIPS:
Reports to an Associate Manager/Manager/Senior Manager of Site Management (SM) within CTM. Accountable for actively participating in internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators 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.
PROJECT SUPPORT:
- Accountable for any mass mailings or communications required to support study execution as directed by PM or Lead CRA.
- Assist the team in preparation for audits or inspections of Trial Master File (TMF).
- Compiles key study information for various systems into a report format for tracking and trending metrics for Lead CRA.
- Coordinate internal receipt and routing of all Serious Adverse Events (SAE) reports to the project team and to Product Safety and Surveillance. Responsible for tracking of receipt.
- Distributes and tracks receipt of regulatory document packages and all trial related documents to study sites, maintains all trackers for essential trial related documents.
- Distributes study related documents and correspondence to study sites and updates respective ITF checklist.
* Distributes, tracks, collates and summarizes feasibility information and provides to Lead CRA/PM.
- Distribution of Investigational New Drug (IND) safety letters to sites. Responsible for tracking of receipt.
- Generate potential site information from INVESTIGATOR database.
- Generates Investigator Meeting certificate of attendance and other site level training certificates
- Provides administrative support to study team as needed for administrative tasks (i.e. meeting minutes.)
- Responsible for properly coding clinical trial documents for archives for the life cycle of the clinical trial and assures that documents are sent for archiving on a regular basis. May assist with review of TMF at direction of Lead CRA or In-House CRA.
- Track protocol deviation signatures.
- Tracks all clinical trial documentation generated by the In-House CRA.
- 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 NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made. Accountable to ensure that all such documents are filed/uploaded accurately and within expected timelines in multiple systems.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
- Upon notification from In-House CRA, updates entries of mandatory event dates into IMPACT. Upon notification from In-House CRA, activates site in IMPACT.
TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- May provide support of training needs across CTM.
PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel.
- Office Based in Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science-related discipline or equivalent proven experience
required in a clinical trial experience within a pharmaceutical, biotechnology, CRO company or healthcare setting.)
- 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 (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 20 - 30%
Title Clinical Trial Coordinator
Job Category Clinical
Job Description PURPOSE:
Responsible for the administrative support to study team and maintenance of key information in various systems in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations. Close collaboration with other members within Clinical Trial Management (CTM).
RELATIONSHIPS:
Reports to an Associate Manager/Manager/Senior Manager of Site Management (SM) within CTM. Accountable for actively participating in internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators 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.
PROJECT SUPPORT:
- Accountable for any mass mailings or communications required to support study execution as directed by PM or Lead CRA.
- Assist the team in preparation for audits or inspections of Trial Master File (TMF).
- Compiles key study information for various systems into a report format for tracking and trending metrics for Lead CRA.
- Coordinate internal receipt and routing of all Serious Adverse Events (SAE) reports to the project team and to Product Safety and Surveillance. Responsible for tracking of receipt.
- Distributes and tracks receipt of regulatory document packages and all trial related documents to study sites, maintains all trackers for essential trial related documents.
- Distributes study related documents and correspondence to study sites and updates respective ITF checklist.
* Distributes, tracks, collates and summarizes feasibility information and provides to Lead CRA/PM.
- Distribution of Investigational New Drug (IND) safety letters to sites. Responsible for tracking of receipt.
- Generate potential site information from INVESTIGATOR database.
- Generates Investigator Meeting certificate of attendance and other site level training certificates
- Provides administrative support to study team as needed for administrative tasks (i.e. meeting minutes.)
- Responsible for properly coding clinical trial documents for archives for the life cycle of the clinical trial and assures that documents are sent for archiving on a regular basis. May assist with review of TMF at direction of Lead CRA or In-House CRA.
- Track protocol deviation signatures.
- Tracks all clinical trial documentation generated by the In-House CRA.
- 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 NovoDOCs, iSITE, EDC administration and updates, and ensure CSIM entries and updates are made. Accountable to ensure that all such documents are filed/uploaded accurately and within expected timelines in multiple systems.
- Responsible to maintains focus, locally, for specific project activities within CMR priorities.
- Upon notification from In-House CRA, updates entries of mandatory event dates into IMPACT. Upon notification from In-House CRA, activates site in IMPACT.
TRAINING:
- Attend relevant symposia, conferences and scientific meetings, as necessary
- May provide support of training needs across CTM.
PHYSICAL REQUIREMENTS:
- Approximately 20% overnight travel.
- Office Based in Princeton, NJ.
KEY SUCCESS FACTORS: EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS
- A Bachelors’ degree (in science-related discipline or equivalent proven experience
required in a clinical trial experience within a pharmaceutical, biotechnology, CRO company or healthcare setting.)
- 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 (2)
Position Location US - Princeton, NJ
City Princeton
State/Provinces US - NJ
Degree Required Bachelor's Degree or equivalent experience
Percent Travel 20 - 30%