Senior Clinical Research Associate (Sr CRA) is responsible for supervising, monitoring, and supporting the administration and progress of clinical trial(s) on behalf of Heron Therapeutics, Inc. The Sr CRA monitors the research procedures and ensures that researcher's follow the proper clinical trial protocol at all times to obtain the correct data. The Sr CRA also ensures that these processes are performed in line with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonisation - Good Clinical Practice (ICH-GCP).
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Identify and assess the suitability of facilities to be used as the clinical trial site (qualify site).
- Identify/select an investigator who will be responsible for the conduct of the trial at the trial site.
- Liaise with doctors/consultants or investigators on conducting the trial.
- Set up the trial sites; ensuring each site has the trial materials, including the investigational product.
- Coordinate study supplies at all sites.
- Train the site staff during the SIV and at other times to trial-specific industry standards.
- Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis.
- Verify that data entered on/in to the case report forms (CRFs) is consistent with patient clinical notes or source data/document verification (SDV).
- Track patient enrollment and recommend solutions to increase appropriate enrollment of qualified subjects.
- Assist and support data query process.
- Collect trial materials throughout and at the end of the study.
- Write monitoring visit reports, and file/collate trial documentation and reports.
- Close trial sites on completion of the trial and perform associated close-out activities.
- Archive study documentation and correspondence as appropriate.
- When performing trial activities, assure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols.
- Assure regulatory compliance of investigational sites with Heron Therapeutics SOPs, FDA regulations, and ICH guidelines.
- Assist in coordination of data management activities.
- Co-monitor with contract research organizations and review site monitoring reports.
- Function as protocol team lead as needed.
- Ensure trial master files are current and maintained.
- Review site informed consent forms and site related materials.
- Prepare study documents such as the Clinical Monitoring Plan, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, and Informed Consents.
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation materials, and source documents.
- Assist with protocol development and final clinical study report completion.
- Plan and participate in investigator meetings.
- Assist with management of CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
- Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above)
- Clinical research, or life science degree preferred
- Advanced degree are preferred
- Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred
- Five or more years of relevant experience with at least one year of experience in a pharmaceutical/biotech company
- Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations
- Demonstrated ability to work independently and in a team environment
- Proficiency with MS Office
- Excellent oral and written communication skills and strong organizational abilities
- Ability and willingness to travel 50% - 80% of the time (internationally and domestically)
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties