Senior/Principal Clinical Research Associate - Vaccine or Infectious disease exp
Remote/Home-based - prefer CRA's based near or in: KS, MO, OH, WI, MI, FL
Who We Are
Synteract, a Syneos Health company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to lifeTM, we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
The Senior Clinical Research Associate is responsible for the monitoring of clinical trials and tracking of study progress, thereby contributing to the overall management of clinical trials in accordance with the appropriate quality standards including ICH-GCP guidelines, Standard Operating Procedures (SOPs), applicable regulations, rules and guidance. S/he is responsible for clinical site start-up, maintenance, and closure activities, including maintenance of study documents. For this role, we are seeking CRA's with vaccine or infectious disease experience. Target locations include KS, MO, OH, WI, MI, FL.
Specific tasks would include:
Interfaces with study team to ensure timely initiation and completion of clinical trials
Responsible for the identification, evaluation and qualification of investigators and sites
May prepare and submit essential document packages to clinical sites required for clinical site initiation. Collects and reviews essential documents received from clinical sites to ensure all required documents are obtained, accurate and complete
May assist with the preparation, review and submission of all relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs
Assists with the ongoing management of the Trial Master File (TMF) and/or Investigator Site Files ensuring essential documents are filed appropriately; assists with the file review and reconciliation process in preparation for audits and archival
Assists with maintaining and updating project-related data in an existing database, e.g. CTMS, eTMF, etc.
Reviews Patient Information Sheet /Informed Consent Forms (PIS/ICFs) and/or data protection authorizations as required
Performs on-site monitoring activities of clinical studies and escalates major site issues to the Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in monitoring reports and follow-up correspondence. Site visits and associated tasks are completed with oversight until authorized to be performed independently
Collaborates with the CTM/PM to ensure study milestones are met, e.g. enrollment, data cleaning, etc.
Reviews and manages data on site and remotely; resolves issues on a continuous basis to achieve timely database lock targets
Responsible for escalating study issues to the CTM/PM and/or Line Manager (LM) in a timely manner
Responsible for training of site staff and communicating directly with investigative sites to provide study direction, answer questions, assess recruitment rates and respond to sponsor requests
Responsible for continuous site management to include remote data review, ongoing collection and review of essential documents, and timely query and action item resolution
Monitors and reports study progress/status on a site level
Prepares or contributes to study related correspondence including, but not limited to, meeting minutes, tracking spreadsheets and the preparation of presentations
Represents Synteract and Clinical Operations at study team meetings
Prepares sites for audit(s) by sponsor or inspection(s) by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses and resolution
May also include:
Assistance with the translation process of study documents
Coordination and assistance with investigator/site contract preparation and negotiation
Coordination and assistance with feasibility studies
Assistance with processing of clinical investigator payments, study expense reports and other financial items
Attendance and participation in customer facing meetings
Assistance in the planning, organizing and executing of project-specific meetings including, but not limited to, client, CRA, and Investigator Meetings
Conducting CRA assessment visit(s)
Contributing to local, regional or global initiatives
Subject matter expert for given system/tool
Bachelor's degree in a life science or related field of study; or equivalent combination of studies, nursing qualifications, and/or work experience
Minimum of 4 years applicable relevant experience, to include independent monitoring
AML (Acute myeloid leukemia) experience is required!
In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules and guidance, as applicable
Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses, and through membership in relevant industry/professional associations.
Proven IT proficiency and skills including Microsoft Office
Effective time management and organizational skills
Effective verbal and writing skills; English and local language, if relevant
This position requires the ability to perform varied tasks, to maintain an appropriate work pace, to exercise logic and reasoning, and to comprehend and follow instructions
This position requires the ability to travel 50-75% and may include overnight travel
Must have a valid driver's license
Performing the duties of this job regularly involves speaking and listening, repetitive hand movement (at least 15 minutes), and sitting for long periods of time; involves some standing, walking, grasping, reaching and lifting of up to 10 pounds. Specific vision abilities include close vision and the ability to adjust focus. (US requirement only)
This job excludes Colorado applicants.
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.