Contract CRA (1099)
- Experience Level
- Experienced (non-manager)
Contract CRA – USA – Phase II Pancreatic Cancer Study – 0.5 FTE/50% Allocation
Upsilon Global are working with a small CRO who have recently won the bid for an exciting Phase II Oncology study, in Pancreatic Cancer. Because of this, we are looking for 3x American CRAs with previous and recent Oncology experience.
As the bid for this study has just been won, the project will be starting around January 2021. There will be approximately a 4-month study start-up period, followed by 12-13 months of monitoring, followed by the close-out. Because of this, we are looking for CRAs with strong study start-up experience in regulatory submissions, site feasibility and site selection responsibilities, as well as general experience in managing the full cycle of a clinical trial.
This CRO are still expanding and as such, this presents a fantastic opportunity for repeat business as this study is the first in a healthy pipeline of studies with sites in the US. This CRO, for this study, are working with an American sponsor, but work with a range of Sponsors across the world.
Details confidential, information available upon request. Specialist and Niche CRO with major expansion plans across Europe and North America. Extremely well respected with close relationships with their Sponsors, based on a long-standing reputation of high-quality delivery in highly scientific protocols.
- Draw up and submit all regulatory submissions in order to gain approval to conduct study
- Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits
- To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
- Ensure that all study related communication including e-mail is tracked, printed and filed as required
- To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
- To liaise with all other appropriate departments to ensure the smooth running of the study
- Mentor and train other CRA’s as and when required
- Perform document submissions to local authorities
- To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
- Other Ad-Hoc CRA duties
Education and Qualifications
- A BSc or BA degree in a lifescience related field
- 10 years’ experience as a clinical research associate
- Proven Oncology background essential. You would ideally be an 'Oncology Specialist', with extensive Phase I and Phase II experience.
- Sound knowledge of ICH/GCP and regulatory requirements and proven background in successful regulatory submissions
- Experience using clinical trial management systems
- Knowledge of RA/EC Submissions in the US highly desired