CRA Lead

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit Job Description Clinical Research Associate Lead Location: Cambridge, MA Duration: 9 months with possibility to extend Objective of the mission: Take responsibility for coordinating and co‑monitoring assigned clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, to deliver clinical development objectives with quality, timely delivery and within budget. Key accountabilities and activities: Coordinate clinical study activities within a matrix organization and support the Global Clinical Project Manager and other clinical study team members. Oversee CRO activities and ensure clinical activities coordination and coaching. Drive study start‑up activities, oversee CROs/CRAs, ensure timely collection of essential study documents, and control set‑up activities prior to each site initiation. Support and ensure completion of Ipsen/CRO EDC system tasks and other clinical tools under the CRA’s responsibility. Assist in training CRO CRAs on study‑specific operational activities and collaborate on the organization and preparation of monitoring and investigator meetings. Produce and review clinical monitoring documents, validate study documents as defined in the study plans, review and approve site visit reports, and follow up on issues raised by CRAs. Conduct site co‑visits/co‑monitoring visits, identify and solve issues in study progress, and coordinate with CRAs and investigators. Manage CRO relationships, assist CRAs as needed, and participate in ongoing clinical study data reviews. Report in CTMS (Ipsen Clinical Trial Management Tracking System) with regular quality checks and ensure data collection (CRF/eCRF) progresses as planned. Participate in TMF review with the study CTA to ensure adequate completion and final thorough review at trial end. Prepare and follow up on other study systems (e.g., IWRS/IMP forecasting/flow) and participate in preparation of study documents and pre‑audit and audit activities. Qualifications Experience / Qualifications: Minimum 2 years in coordination of clinical monitoring activities of international clinical development trials (Phase II–III). Minimum 2 years as a Field CRA (CROs or Pharma Industry). Experience in oncology studies. Good knowledge of Good Clinical Practice (GCP), ICH regulations, FDA and EU regulations. Experience managing and developing relationships with Contract Research Organisations (CROs). Technical Competencies & Skills: Strong organization, coordination and interpersonal skills. Excellent verbal and written communication skills in English. Good computer literacy. Anticipatory and proactive attitude. Ability to work within a team and multidisciplinary, matrix environment. EEO Statement All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Real Staffing