Clinical Research Assistant II Job
- Recruiter
- Celgene
- Location
- Greater London
- Salary
- Competitive
- Posted
- 26 May 2015
- Closes
- 31 May 2015
- Sectors
- Travel & Tourism
- Contract Type
- Permanent
- Hours
- Full Time
Manage Investigative Site activities to ensure that subject safety is protected and that timely high quality data are collected in compliance with regulations
Responsibilities include, but are not limited to:
1. Monitor assigned investigative sites
Plan and conduct pre-study, initiation, interim monitoring and close-out visits
Train assigned investigative sites in GCP/ICH and ensure these sites are conducting research
according to protocol and regulations
Review investigative sites' regulatory documentation and ensure compliance with GCP/ICH
Monitor compliance with protocol, informed consent process, drug accountability, GCP/ICH and
applicable local laws
Serve as main point of contact with assigned investigative sites
Review and train sites in updating clinical files in compliance with GCP/ICH
Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP
/ICH
Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a
valid representation of what happened to a subject while participating in the study
Organize delivery of supplies (eg study medication, lab kits, CRFs) as required
Monitor inclusion rate and discuss action plan to ensure completion of the study within planned
timelines
Create and properly file trip reports, follow-up letters and telephone contacts for assigned
investigative sites
2. Evaluate and Resolve Data Queries
Evaluate study query trends and interact with Study Team in improving data quality
Work with Data Management and assist investigative sites to achieve timely and accurate
resolution of queries
3. Attend, participate and present at Investigator meetings
4. Effectively negotiate and manage clinical study budgets and contracts for assigned sites
5. Act as a liaison between Celgene and assigned investigative sites
6. Identify new investigators for future Celgene studies
7. Assist in Review draft CRF and provide feedback as required
8. Participate in study team meetings
9. Assist in mentoring new CRAs, as requested
10. Assist IRB/IEC-submissions/correspondence eg
Compile submission dossier in consultation with the investigator
Adapt patient information and consent form to local regulatory requirements to ensure approval
Ensure translation and back translation of study specific documents as required
Send annual reports to IRBs/IECs as required
Update submissions, eg protocol amendments, safety reports 01-Feb-2008
Notify IRBs/IECs about study completion/termination
11. Up to approximately 80% domestic travel required, including overnight stays
12. Comply with Celgene's travel policy
Qualifications
Skills/Knowledge Required:
Prior experience as a Clinical Research Associate
Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated
tactfulness and diplomacy in dealing with study coordinators and physicians
Experience in study/site set up
Able to resolve routine issues independently
Knowledge of regulatory environment (ICH, GCP, EU CT Directive, local laws)
Excellent written and oral communication skills
Fluent written and spoken English
Working knowledge of SOPs relevant to clinical research
Current, clean driver's license
Prior hematology/oncology clinical study experience
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
Our purpose as a company is to discover and develop therapies that will change the course of human health.
We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
*LI-KL1
*MONEU
*LI-PRIORITY
Req ID:
Primary Location: United Kingdom-England-Hillingdon
Job: Research and Development
Organization: Celgene UK Marketing LTD
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 75 % of the Time
Job Posting: 2015-04-:00:00.0
Responsibilities include, but are not limited to:
1. Monitor assigned investigative sites
Plan and conduct pre-study, initiation, interim monitoring and close-out visits
Train assigned investigative sites in GCP/ICH and ensure these sites are conducting research
according to protocol and regulations
Review investigative sites' regulatory documentation and ensure compliance with GCP/ICH
Monitor compliance with protocol, informed consent process, drug accountability, GCP/ICH and
applicable local laws
Serve as main point of contact with assigned investigative sites
Review and train sites in updating clinical files in compliance with GCP/ICH
Initiate actions to ensure all assigned investigative sites are in compliance with protocol and GCP
/ICH
Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a
valid representation of what happened to a subject while participating in the study
Organize delivery of supplies (eg study medication, lab kits, CRFs) as required
Monitor inclusion rate and discuss action plan to ensure completion of the study within planned
timelines
Create and properly file trip reports, follow-up letters and telephone contacts for assigned
investigative sites
2. Evaluate and Resolve Data Queries
Evaluate study query trends and interact with Study Team in improving data quality
Work with Data Management and assist investigative sites to achieve timely and accurate
resolution of queries
3. Attend, participate and present at Investigator meetings
4. Effectively negotiate and manage clinical study budgets and contracts for assigned sites
5. Act as a liaison between Celgene and assigned investigative sites
6. Identify new investigators for future Celgene studies
7. Assist in Review draft CRF and provide feedback as required
8. Participate in study team meetings
9. Assist in mentoring new CRAs, as requested
10. Assist IRB/IEC-submissions/correspondence eg
Compile submission dossier in consultation with the investigator
Adapt patient information and consent form to local regulatory requirements to ensure approval
Ensure translation and back translation of study specific documents as required
Send annual reports to IRBs/IECs as required
Update submissions, eg protocol amendments, safety reports 01-Feb-2008
Notify IRBs/IECs about study completion/termination
11. Up to approximately 80% domestic travel required, including overnight stays
12. Comply with Celgene's travel policy
Qualifications
Skills/Knowledge Required:
Prior experience as a Clinical Research Associate
Must have demonstrated problem-solving abilities in overseeing clinical sites, and demonstrated
tactfulness and diplomacy in dealing with study coordinators and physicians
Experience in study/site set up
Able to resolve routine issues independently
Knowledge of regulatory environment (ICH, GCP, EU CT Directive, local laws)
Excellent written and oral communication skills
Fluent written and spoken English
Working knowledge of SOPs relevant to clinical research
Current, clean driver's license
Prior hematology/oncology clinical study experience
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
Our purpose as a company is to discover and develop therapies that will change the course of human health.
We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
*LI-KL1
*MONEU
*LI-PRIORITY
Req ID:
Primary Location: United Kingdom-England-Hillingdon
Job: Research and Development
Organization: Celgene UK Marketing LTD
Schedule: Regular
Shift: Standard
Employee Status: Individual Contributor
Job Type: Full-time
Job Level: Day Job
Travel: Yes, 75 % of the Time
Job Posting: 2015-04-:00:00.0