Senior Clinical Research Associate - *AML required*Home-based - preferred locations KS, MO, MI, OH, MN, COWho We Are
Synteract 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 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, AML (Acute myeloid leukemia) experience is required! Role is remote with preferred locations in KS, MO, MI, OH, MN, CO.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)
If you're passionate about bringing clinical trials to life, we encourage you to apply today!
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.