Post: Clinical Research Associate
Juno Therapeutics is expanding our Clinical Operations Team. We are looking for highly-motivated individuals looking for challenge in the immune-oncology arena. We are currently looking for experienced Clinical Research Associates to work with our collaborating clinical trials at busy academic sites. The Clinical Research Associate II will play a key role in supporting the Juno Extramural Program and the conduct of associated Investigator Initiated Clinical Trials. Required skills include logical thinking, ability to prioritize, a “can do” attitude, the ability to adapt quickly to changing conditions and team building. The successful candidate will possess strong communication skills and have experience working in a fast-paced environment within the biotech/pharmaceutical industry.
The Clinical Research Associate (or CRA II), reporting to the Associate Director, Clinical Operations and under the direction of the Extramural Clinical Study Manager, will work closely with a cross functional team to achieve study objectives and corporate goals. Primary responsibilities may include the following:
Develop strong working relationships and effective communication with collaborating study teams, Juno Clinical Development and other Juno functional departments.
Perform data verification visits, including generation of visit reports for studies under Investigator held INDs.
- Collaborate with field-based monitoring staff to assist in data verification activities.
- Provide study training to field-based CRAs, manage CRA site assignments and data verification visit schedules and review and approve data verification visit reports.
- Track and escalate study issues to the Extramural Study Manager.
- Author Data Verification Plans for investigator held IND studies. Assist in development of operational plans.
- Provide timely, quality study metrics to study teams using a variety of tracking tools (tables, databases, spreadsheets and files).
- Work with specialty lab vendors and research scientists to manage laboratory sample transfer from collaborative trial sites to specialty labs.
- Review completed eCRFs or data listings for accuracy, oversee data discrepancy management, and perform associated training/retraining as needed.
- Work proactively with data management (at Juno and at collaborating institutions) in the design and development of eCRFs, data cleaning and data review or transfer schedules
- 4+ years pharma/biopharma industry experience in complicated oncology drug development, hematology oncology or gene therapy trials.
- 2+ years on-site monitoring experience, preferably at large cancer treatment centers. Experience with Phase 1 and 2 clinical trials, gene therapy trials, and/or nursing in a clinical setting desired.
- Supervisory experience of remotely based CRA staff preferred.
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Previous experience with electronic data capture systems, with Medidata RAVE™ EDC experience preferred.
- Demonstrated ability in positive relationship building, with strong verbal and written skills.
- Strong interpersonal skills, ability to work within a team, and attention to detail.
- Good analytical and assessment skills, judgement, and problem solving skills.
BS/BA in life science or related discipline.
click above download