The Senior Clinical Research Associate will be responsible for initiation, monitoring and other tasks associated with the study management of clinical studies. The Senior Clinical Research Associate will also be responsible for site management for clinical studies and will assist in the creation and implementation of protocols, informed consents, case report forms, clinical study reports and related study materials. The role will also provide guidance, clinical trial management and direction to other junior clinical team members.
Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
Serve as clinical contact for a study including CROs/vendors, Investigators and study coordinators
Actively participate in the implementation and execution of clinical trial activities from study planning through closure
Support the Clinical Study Manager and/or Director of Clinical Research with vendor selection and vendor management, including the Contract Research Organization (“CRO”) and other clinical study vendors (Central Lab, IVRS, Scale Management, etc.)
In conjunction with the Clinical Study Manager and/or Director of Clinical Research, manage site selection process for clinical studies
Assist and support development and review of clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Case Report Forms, Source Documents, Monitoring Plan, Data Management Plan, Project Management Plan, etc.)
May accompany CRO/CRA’s to monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCP’s), SOP’s and study protocols
May perform site qualification, initiation, monitoring, and/or close out site visits
Assist in management and oversight of CRO in terms of the approved study budget and compliance to SOPs, and CRO personnel in terms of performance including selection and termination
Order and coordinate study supplies for clinical studies
Develop and maintain tracking tools to support management of clinical studies
Participate in site budget negotiations
Assist in review of vendor contracts and budgets
Assist in developing and managing study timelines
Plan and participate in Investigator meetings and CRA trainings
Assist and support data validation and data clean procedures
Assure regulatory compliance of investigational sites with SOP's and FDA and ICH
Minimum of 8+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.
Experience in protocol development/writing is preferred
Strong, relevant therapeutic experience in pharmaceutical/biotechnology clinical trials
Experience in selection and management of vendors/CROs (Central Lab, IVRS, EDC); previous experience as a Lead CRA or Clinical Team Lead is highly preferred
Experience in international or global clinical trials is preferred
Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU directive, and other relevant, local regulatory requirements
Experience in leading and working within functional teams
Good knowledge of concepts of clinical research and drug development
Ability to handle and prioritize multiple studies and projects
Ability to work effectively in a team/matrix environment
Ability to understand technical, scientific and medical information
Demonstrated strengths in planning, organizational, project management, analytical skills, oral and written communication, time management, conflict management, problem solving, attention to detail, and interpersonal skills
Strong computer skills
Ability to travel up to 25% travel including ground and air
Position generally requires BA/BS or RN, preferably in the Life Sciences; Advanced degree
***This position is in-house and does not offer relocation to the So. California area.
Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) is a biopharmaceutical company focused bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.
The U.S. Food and Drug Administration (FDA) recently approved NUEDEXTA™ (dextromethorphan HBr and quinidine sulfate), for more information please visit www.nuedexta.com.