What are the responsibilities and job description for the Principle Clinical Research Associate position at Exokeryx?
Job Title : Principle Clinical Research AssociateLocation : RemotePosition type : Full timeFLSA : ExemptDepartment : Clinical OperationsFinance ID : 2101-J36190-BFStrive to Bring a Profound Difference to our Patients At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases : myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter .The Opportunity The Principal Clinical Research Associate (PCRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure successful execution of clinical monitoring. PCRAs have expertise in on-site and remote clinical trial monitoring and oversight, ensuring subject safety, protocol compliance and data integrity, and implementation of clinical trial documents and plans. As an Avidity representative in the field, the PCRA will support establishing, building, and maintaining collective relationships with KOLs, investigators and site staff. The PCRA is relied upon to instill, promote, and maintain a culture of organizational excellence and monitoring team collaboration. Strong initiative, organizational skills, and leadership by example required.What You Will Contribute May review data quality reports for trends and escalation of monitoring issues.Assist clinical trial team with oversight of CRO monitoring activities, assumptions, and metrics, including site qualification, site initiation, interim monitoring, and close out visits.Assist CTM with setting expectations for monitoring report content as outlined in the annotated report, and finalization of associated reports and follow-up letters; escalate deficiencies or quality issues to CTM.Conduct Oversight Visits to assess the Clinical Research Associate (CRA) and / or site performance to evaluate data integrity, compliance with the protocol, Good Clinical Practice (GCP), and any applicable local / regional regulations.Assist with the review of CRO clinical monitoring Standard Operating Procedures (SOPs), processes, and best practices to ensure Avidity monitoring expectations are met.Participate in User Acceptance Testing (UAT) for EDC, IRT, and study vendor portals; review at initial launch and with amendments, as needed.Review clinical trial documents such as clinical monitoring plans, study operations manual, monitoring visit report and letter templates, case report forms (CRF) and CRF completion guidelines, site tools and worksheets, and other study documents requiring clinical review as needed.Participate in the identification and review of trial-specific EDC data tracking and metrics.Work with Data Manager and CTM to review data listings for accuracy, support data discrepancy management, and provide training / retraining to site staff and CRAs as needed.Collaborate, develop, and deliver study-specific training for CRO clinical study team, field CRAs, investigative site staff, and vendors.Assist with planning and attend investigator meetings (IM); may present during CRA training.Attend, present, and train investigative site staff during site qualification visits and site initiation visits, as required.Assist with investigative site regulatory inspection preparation, support, and follow-up.May participate in vendor capabilities presentations and bid defense meetings for vendor identification and selection.May participate in and support corporate patient advocacy efforts.Represent Avidity monitoring oversight initiatives and, if appropriate, facilitate cross-functional study collaboration.Contribute to ongoing process improvement and department initiatives.Participate in corporate collaboration meetings and attend industry meetings and conferences.Travel as needed per study status and timelines, in addition to other essential study meetings (i.e., Investigator meetings, study kick-off meetings, bid defenses, vendor meetings, etc.).What We Seek Bachelor’s Degree or equivalent combination of education and experience in science or health-related field. Advanced Degree preferred.8 years of industry experience conducting clinical site monitoring, management, and oversight; elements of clinical trial management also preferred.Knowledge of regulatory and compliance requirements for clinical research, including but not limited to, US CFR, ICH, GCP, GDP, EU / UK GDPR.Team leadership experience within a cross-functional matrix environment.Demonstrated excellent presentation, communication (oral and written), teamwork, organizational, interpersonal, and critical thinking skills.What We will Provide to You : The base salary range for this role is $169,100 - $186,900. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.A commitment to learning and development which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.Avidity Biosciences10578 Science Center Dr. Suite 125San Diego, CA 92121O : 858-401-7900F : 858-401-7901#J-18808-Ljbffr
Salary : $169,100 - $186,900
