This senior clinical research associate role involves monitoring clinical research studies to ensure they are conducted according to accepted clinical practices. It suits a professional with a drug development mindset who can navigate complexity and accelerate progress in a fast-paced environment.
Responsibilities
Perform site qualification, site initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP, GPP, and protocol compliance
Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team and develop action plans
Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate
Demonstrate diligence in protecting the confidentiality of each subject/patient
Assess factors that might affect subject/patient
Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assess site processes
Conduct Source Document Review of appropriate site source documents and medical records
Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines
Utilize available hardware and software to support the effective conduct of the clinical study data review and capture
Verify site compliance with electronic data capture requirements
May perform investigational product (IP) inventory, reconciliation and review storage and security
Verify the IP has been dispensed and administered to subjects/patients according to the protocol
Verify issues or risks associated with blinded or randomized information related to IP
Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned
Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness
Reconcile contents of the ISF with the Trial Master File (TMF)
Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan
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Support subject/patient recruitment, retention and awareness strategies
Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution
Understand project scope, budgets, and timelines for own and others
May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate
Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements
Prepare for and attend Investigator Meetings and/or sponsor face to face meetings
Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project specific requirements
Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions
May provide training or mentorship to more junior level CRAs
May perform training and sign off visits for junior CRA staff, as assigned
May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager
For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I. Additional responsibilities include:
Site support throughout the study lifecycle from site identification through close out
Knowledge of local requirements for real world late phase study designs
Chart abstraction activities and data collection
As required, collaborate and build relationships with Sponsor and other affiliates, medical science liaisons and local country staff
Identify and communicate out of scope activities to Lead CRA/Project Manager
Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations
Identify operational efficiencies and process improvements
Develop country level informed consent forms
Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared
Participate in bid defense meetings
Requirements
Bachelor
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Good computer skills and ability to embrace new technologies
Excellent communication, presentation and interpersonal skills
Basic level of critical thinking skills
Ability to manage required travel of up to 75% on a regular basis
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
About the Company
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They partner with innovators across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past 5 years, they have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.
