Avidity Biosciences, Inc

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.. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs).. The Senior Clinical Research Associate (Sr. CRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure study subject safety, and successful data collection and integrity of the clinical trial.. Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF).. Work with Medical Monitor, Data Manager, Safety Manager, Clinical Operations Program Lead, Clinical Trial Manager, Clinical Trial Associate, Principal CRA, and CRO staff to review site specific data listings for accuracy, data discrepancy resolution, and data trends; provide training/retraining to site staff as needed.

senior clinical research associate

Job Title:
Senior Clinical Research Associate
Location:
Remote
Position type:
FLSA:
Full time
Exempt
Department:
Clinical Operations
Strive 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). 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. 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 Senior Clinical Research Associate (Sr. CRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure study subject safety, and successful data collection and integrity of the clinical trial. Sr. CRAs have extensive experience conducting on-site and remote clinical trial training and monitoring, verifying protocol compliance, comprehension and implementation of clinical trial documents and plans, and vendor and site management. As an Avidity representative in the field, the Sr. CRA will support the clinical study team in establishing, building, and maintaining collective relationships with KOLs, investigators, and site staff. The Sr. CRA is relied upon to ensure all local and regional regulations and guidelines are followed, including but not limited to, US CFR, ICH, GCP, GDP, EU/UK GDPR. The Sr. CRA will support the Avidity Clinical Operations culture of organizational excellence and team collaboration. Strong initiative, organizational and problem-solving skills, and leading by example are required. This position may be remote or based in San Diego.
What You Will Contribute
* Monitor study site activities to ensure the rights, safety, and wellbeing of research subjects, and adherence to study protocols, informed consent, and HIPAA compliance.
* Conduct monitoring visits and associated activities for site qualification, site initiation, interim monitoring, and close out visits; ability and experience writing detailed monitoring reports and visit confirmation and follow-up letters.
* Present and train investigative site staff during site qualification visits, site initiation visits, and throughout the study as required.
* Proficiency in adverse event reporting and validating all study data, IP dispensation, and source documentation.
* Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF).
* May conduct co-monitoring visits and oversight assessment visits with CRO field CRAs.
* Review and follow study Standard Operating Procedures (SOPs), processes, and best practices to ensure trial expectations are met.
* May assist in the review of clinical trial documents such as informed consent forms, study manuals, forms, templates, case report forms (CRF), CRF completion guidelines, visit materials, training materials, site tools, and worksheets, etc.
* Ability to understand and successfully meet the clinical expectations of trial-specific data tracking and metrics.
* Work with Medical Monitor, Data Manager, Safety Manager, Clinical Operations Program Lead, Clinical Trial Manager, Clinical Trial Associate, Principal CRA, and CRO staff to review site specific data listings for accuracy, data discrepancy resolution, and data trends; provide training/retraining to site staff as needed.
* Competence in risk identification and deficiencies, protocol deviation tracking, and management; recognize when escalation is required.
* Ability to effectively communicate, respond to challenging issues, and identify collaborative resolution.
* Assist with investigative site inspection preparation, support, and follow-up.
* Attend and participate in investigator meetings.
* Participate in corporate collaboration meetings and attend industry meetings and conferences.
What We Seek
* Bachelor's Degree required
* 5+ years of industry experience conducting clinical site monitoring and clinical site management.
* Travel is required for this position, averaging approximately 3-4 site visits a month (may increase or decrease with the needs of the study); ability to travel globally, if needed.
* Experience and knowledge of working in different EDC systems.
* Knowledge of regulatory and compliance requirements for clinical research, including but not limited to, US CFR, ICH, GCP, GDP, EU/UK GDPR.
* Demonstrated excellent presentation, communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
* Excellent time management and prioritization of tasks to accomplish goals and meet study timelines and deliverables efficiently and successfully.
What We will Provide to You:
* The base salary range for this role is $138,500.00-$153,100.00. 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 Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O: 858-401-7900
F: 858-401-7901<br/><br/>#J-18808-Ljbffr

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