Senior Clinical Research Associate

Sr. Clinical Research Associate (Sr. CRA)

The Sr. Clinical Research Associate (Sr. CRA) will independently manage all clinical aspects of a small to medium-sized clinical study or, with supervision, assume significant management responsibilities on a large-scale study. This position works closely with a cross-functional team, vendors, sites, and CRO to ensure compliance with protocol and the overall clinical trial objectives. Additionally, this role will be responsible for implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols. This role will report to a Sr. CTM or Associate Director. Hybrid SSF preferred with remote considered.

Job Responsibilities:

• Serves as a crucial member of the project team for the quality execution of assigned clinical protocols according to SOPs, ICH/GCP, and corporate and departmental program goals.
• Supports the Study Lead as an integral member of a multifunctional team to ensure clinical study activities including study start-up, enrollment, maintenance, and closeout are executed appropriately.
• Participates in protocol development, tracking changes for future protocol amendments, and works with medical writing to initiate protocol amendments as needed.
• Oversees aspects of study management and vendors (e.g. IRT, eCOA, cardiac safety, patient reimbursement vendors) to ensure high quality of data and to ensure study execution and deliverables are met with minimum supervision.
• Overall management of selected clinical sites including acting as a point of escalation and oversight of CRO monitoring activities, which includes monitoring visit report review, contract and budget negotiations with clinical sites. Assists with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Works with the CTA to ensure creation, tracking, distribution, and accuracy of meeting agendas and meeting minutes.
• Participates in the review/ implementation of study design from an operations perspective and implements tactics at a site level.
• May support Study Lead in the review of CRO/Vendor RFPs and participate in bid defenses and review and comment on proposals for vendor selection.
• Supports Study Lead in the development / review of study timelines and budgets and works diligently to meet timelines and deliverables.
• Participates in the development of critical study documents such as informed consent form templates, site management monitoring tools, FAQs, processes, and workflows.
• Participates in the development, distribution, review, and tracking of essential trial documents.
• Strives to ensure timelines and deliverables are met within budget.
• Participates in the development of and ensures compliance with the clinical monitoring plan; monitors as needed for training and quality assurance (QA) purposes.
• Supports the creation and updates on the study plans, Informed Consent Forms, Feasibility Questionnaires, Qualification Visit presentations, Site initiation visit presentations, site-facing materials and tools from initiation to the final study execution.
• Contributes to the case report form (CRF) design process including content, User Acceptance Testing (UAT), form layout, and edit check review.
• Liaises internally to forecast and monitor overall drug supply throughout the trial.
• Supports other study-wide activities as assigned - such as external vendors, sample handling, investigator payments, overall data quality, and overall central records quality.
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and study drug, safety, regulatory, and legal questions.
• Contributes to the SOP review process and/or other Clinical Operations Initiatives
• Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits.
• Practices professionalism and integrity in all actions and relationships with management, supervisors, team members, and vendors. Demonstrates teamwork, cooperation, self-mastery, and flexibility to get the work done.

Experience:

• Minimum 4 years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting. Global experience a plus.
• A good understanding of the drug development process, ICH guidelines/GCP and understanding of the clinical trials process, the application of SOPs, and medical terminology.
• Self-motivated and able to motivate others.
• Strong interpersonal, problem-solving, organizational, and planning skills along with excellent verbal and written communication skills
• Strong attention to detail and ability to prioritize tasks to meet critical deadlines.
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer

Education:

• Bachelor's degree in a relevant scientific discipline