Clinical Research Associate (In-house/Study start-up)
Clinical Research Associate (In-house) - Carlsbad, CA Office-based
Specific tasks would include:
Who We AreSynteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The 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. This role is an In-house CRA focused on study start-up and is office-based in Carlsbad, CA.
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
- Assistance in the planning, organizing and executing of project-specific meetings including, but not limited to, client, CRA, and Investigator Meetings
- Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience
- Prefer study start up experience, ICF review, IRB submissions, regulatory knowledge, etc.
- Working 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.
- Basic IT proficiency and skills including Microsoft Office
- Basic time management and organizational skills
- Effective verbal and writing skills; English and local language, if relevant.