Integrated Resources, Inc ( IRI )
Senior Clinical Research Associate
Integrated Resources, Inc ( IRI ), Cambridge, Massachusetts, us, 02140
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Delivery Lead - Recruitment at Integrated Resources, Inc ( IRI )
Pay range - $45/hr-$55/hr Summary / purpose of the position Take responsibility for coordinating clinical monitoring activities, overseeing CRO clinical/site management, and co-monitoring assigned international Phase 2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP), SOPs, and quality standards to support Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of clinical study deliverables within a matrix organization under the leadership of Clinical Project Managers (CPM). Represent the company at sites and build relationships with investigators. Responsibilities include: Ensure clinical activities coordination & oversight: Oversee study start-up, working closely with the CROs and relevant teams (DM, Reg, CMC), ensuring feasibility reports are exhaustive, site feasibility reviews, and timely collection of essential documents. Support and ensure completion of EDC system tasks without delays. Assist in training CRAs and organize monitor and investigator meetings. Help evaluate timelines and establish milestones, ensuring quality and timeliness. Prepare and review key documents like monitoring plans and oversight reports. Customize and monitor Key Risk/Performance Indicators. Validate clinical study documents and review site visit reports. Provide guidance to internal CRAs and coordinate CRO relationships. Participate in RFP processes and meetings with Medical Science Liaisons. Monitor clinical study activities: Co-monitor studies per plan, resolve issues, verify data, and follow up with CROs and investigators. Participate in data reviews and ensure timely data entry and queries resolution. Coordinate sample flow and participate in TMF quality reviews. Assist in preparing study documents and site visits for audits. Act as an investigator site CRA or backup CPM as needed. Additional functions: Contribute to SOP updates, training, and cross-department projects. Support integration activities for acquisitions or licensed assets. Compliance and safety: Adhere to EHS regulations, report risks, and participate in training. All activities must comply with *** Group SOPs and documentation. Knowledge, abilities & experience
Education:
CRA graduate, life sciences or medical degree preferred. Experience:
At least 1-2 years as Lead CRA or similar role, with 3+ years as a Field CRA, knowledge of GCP, ICH, clinical documentation, CRO management, and therapeutic area experience is a plus. Skills:
Strong organizational, communication, teamwork, and problem-solving skills; proficiency in software tools; basic financial knowledge; proactive and flexible approach. Seniority level
Mid-Senior level Employment type
Contract Job function
Other Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Pay range - $45/hr-$55/hr Summary / purpose of the position Take responsibility for coordinating clinical monitoring activities, overseeing CRO clinical/site management, and co-monitoring assigned international Phase 2/3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP), SOPs, and quality standards to support Clinical Development objectives and achieve clinical excellence. Coordinate the achievement of clinical study deliverables within a matrix organization under the leadership of Clinical Project Managers (CPM). Represent the company at sites and build relationships with investigators. Responsibilities include: Ensure clinical activities coordination & oversight: Oversee study start-up, working closely with the CROs and relevant teams (DM, Reg, CMC), ensuring feasibility reports are exhaustive, site feasibility reviews, and timely collection of essential documents. Support and ensure completion of EDC system tasks without delays. Assist in training CRAs and organize monitor and investigator meetings. Help evaluate timelines and establish milestones, ensuring quality and timeliness. Prepare and review key documents like monitoring plans and oversight reports. Customize and monitor Key Risk/Performance Indicators. Validate clinical study documents and review site visit reports. Provide guidance to internal CRAs and coordinate CRO relationships. Participate in RFP processes and meetings with Medical Science Liaisons. Monitor clinical study activities: Co-monitor studies per plan, resolve issues, verify data, and follow up with CROs and investigators. Participate in data reviews and ensure timely data entry and queries resolution. Coordinate sample flow and participate in TMF quality reviews. Assist in preparing study documents and site visits for audits. Act as an investigator site CRA or backup CPM as needed. Additional functions: Contribute to SOP updates, training, and cross-department projects. Support integration activities for acquisitions or licensed assets. Compliance and safety: Adhere to EHS regulations, report risks, and participate in training. All activities must comply with *** Group SOPs and documentation. Knowledge, abilities & experience
Education:
CRA graduate, life sciences or medical degree preferred. Experience:
At least 1-2 years as Lead CRA or similar role, with 3+ years as a Field CRA, knowledge of GCP, ICH, clinical documentation, CRO management, and therapeutic area experience is a plus. Skills:
Strong organizational, communication, teamwork, and problem-solving skills; proficiency in software tools; basic financial knowledge; proactive and flexible approach. Seniority level
Mid-Senior level Employment type
Contract Job function
Other Industries
Pharmaceutical Manufacturing and Biotechnology Research
#J-18808-Ljbffr