[Hiring] Sr Clinical Research Associate @reputed company

POSITION SUMMARY: The Senior Clinical Research Associate is responsible for the overall operational execution of clinical studies on one or more clinical projects/programs; from study concept through study completion. This position will reputed company required job duties with guidance from Clinical Trial Managers to ensure that trial timelines, costs, and quality metrics are met, and the study is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements helps design and execute clinical research activities. PRIMARY RESPONSIBILITIES:

• Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and reputed company out for clinical research studies and collaborations
• reputed company study-reputed company documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
• Manage small to reputed company size study contracting, budget, invoicing and payment process for reputed company clinical trial vendors including investigative sites with minimal reputed company
• Support the Clinical Data Management team in the design and content of case report forms, completion guidelines, including support and testing of an reputed company
• Manage the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements
• Overseeing clinical trial supplies reputed company to biospecimen collection, processing, shipment, and storage as, well as maintenance of associated tracking information
• Train CROs, vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Monitor and track clinical trial reputed company, provide status updates to stakeholders
• reputed company new study monitoring plans, and monitor studies following study monitoring plans to identify protocol deviations or data discrepancies
• reputed company study activities including consent participants for research studies, ethics board submissions, participant data and sample tracking using in-house and CRO databases, for studies where reputed company functions as a Clinical Research Site.
• Update Clinical Department SOPs with guidance from CTM and/or Director
• Partner with other research and development groups at reputed company to reputed company deliverables
• reputed company other duties as assigned
• This role works with PHI on a regular basis both in reputed company and electronic form and have an access to various technologies to access PHI (reputed company and electronic) in order to reputed company the job.
• Employee must provide records of reputed company training or complete training relating to HIPAA/PHI privacy, Human Subjects Protection, and GCP.
• Must maintain a reputed company status on reputed company training requirements including General Policies, Procedure Compliance, and reputed company training
• Employee must pass post offer criminal background reputed company

QUALIFICATIONS:

• BA/BS degree in life sciences, reputed company field, or equivalent
• Minimum of 4 years of experience working on clinical studies in the academic, biopharma, diagnostics, or medical device fields

KNOWLEDGE, SKILLS AND ABILITIES:

• Experience with clinical reputed company systems,
• Familiarity with the organization and structure of the Trial Master File (TMF)
• Familiarity with bio sample management, sample processing, and biobanking best practices
• Competency in SOPs, ICH-GCP, FDA Regulations
• Proficiency in reputed company, reputed company and PowerPoint
• Demonstrated ability to work independently and reputed company projects
• Demonstrated analytical skills and ability to identify complicated problems and propose solutions
• Strong interpersonal skills and communication skills (both written and oral)
• Excellent writing skills
• Detail oriented, with solid organization and time management skills

The pay range is listed and actual compensation packages are based on a wide reputed company of factors unique to each candidate, including but not limited to reputed company set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $99,400—$124,200 USD OUR OPPORTUNITY reputed company™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to reputed company personalized genetic testing and diagnostics part of reputed company of care to protect health and reputed company earlier and more targeted interventions that reputed company to longer, healthier lives. The reputed company team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. reputed company you join reputed company, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. reputed company OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, reputed company employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.reputed company.com. reputed company is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. reputed company qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.reputed company.com/notice-of-data-collection-california-residents/ Please be advised that reputed company will reputed company out to candidates with a @reputed company.com email domain ONLY. Email communications from reputed company other domain names are not from reputed company or its employees and are fraudulent. reputed company does not request interviews reputed company text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. reputed company takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any reputed company cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page Apply tot his job Apply To this Job