Clinical Project Associate (Site Payments)

Synteract - USA - Clinical Project Associate I/II (Site Payments) - Morrisville, NC Office-based or Remote 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 life TM , 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. Position Overview The Clinical Project 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. *Please note, this role has the potential to be hired at the Clinical Project Specialist II level depending upon individual experience. This role is based in Morrisville, NC. Responsibilities of the role will be focused in Finance/Site Payments as highlighted below. Must have an interest or experience with numbers or finance to be considered. Work experience required, with CRO or Pharma experience highly preferred. Specific tasks would include: Assists with processing of clinical investigator payments, client/vendor invoices, study expense reports and other financial items, which may include interaction with the study team and accounting. May assist with ensuring finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site.Interfaces with study team to ensure timely initiation and completion of clinical trials 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 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 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 Qualifications Degree in a financially related field of study or similar Minimum of 2 - 5 years applicable experience; CRO industry experience preferred Prior site payments or project finance experience strongly preferred Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations Proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook. Effective verbal and writing skills; English + local language, if relevant. This job excludes Colorado applicants. 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.... - Permanent - Full-time

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