Senior Clinical Research Associate

Job Location: 275 Grove Street, Suite 101C, Newton, MA 02466 and must travel 70%-75% of the time to various and unanticipated sites internationally and throughout the following states: WA, OR, CA, AZ, ID, NV, MT, WY, CO, HI, AR, IA, UT and NM. Expected travel 3-5 days/week. May work from home anywhere in these states (except HI). Home office must be within 30 minutes of national or international airport due to travel obligations.

Job Title: Senior Clinical Research Associate

Duties: Parexel International LLC seeks a Senior Clinical Research Associate based in Newton, MA to monitor and oversee clinical trials at client sites. Evaluate quality and integrity of reported data. Represent the company at assigned clinical trial sites and be accountable for quality and delivery from site identification to the close of trial. Conduct, drive, and manage country-specific feasibility and site pre-qualification and qualification activities, which include preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. Conduct on-site and remote visits/contacts, including Qualification, Initiation, Monitoring, Termination Visits, and Site Motivational Visits, and generate site visit reports. Develop strategy to configure, distribute, and collect, review, and approve high-quality country-specific and site-specific documents, essential regulatory documents, and updated or amended regulatory documentation. Customize, review, and negotiate country/site-specific Informed Consent Forms, translations, and customize and negotiate any amendments. Prepare and submit IRB/IEC and MoH/RA applications, resolve conflicts, and determine appropriate follow-up until receipt of final approval. Address and resolve issues at clinical trial sites, including the need for additional training, potential deficiencies in documentation, and communication. Follow-up on Case Report Form data entry, query status, and Serious Adverse Events. Assess and manage test article/study supply including supply, accountability, and destruction/return status. Review and follow-up on site payment status and ensure site receives payments on a timely manner. Communicate study issues that require immediate action with a proposed strategy for resolution. Ensure assigned sites are audit-ready and inspection-ready. Lead and mentor junior CRAs on process/study requirements and perform assessments and co-monitoring visits. Perform report review of visit reports of junior CRA’s to ensure compliance with GCP and Protocol Guidelines. Guide Administrative Support Team members, review work, and provide feedback to the manager regarding performance. Position must travel 70%-75% of the time to various and unanticipated sites internationally and throughout the following states: WA, OR, CA, AZ, ID, NV, MT, WY, CO, HI, AR, IA, UT and NM. Expected travel 3-5 days/week. May work from home anywhere in these states (except HI). Home office must be within 30 minutes of a national or international airport due to travel obligations. (Ref. # 00946)

Requirements: Bachelor’s Degree in Pharmaceutical Science, Biological Science, Nursing, or related field plus 18 months of experience in clinical research, including: (1) Monitoring and direct site management of pharmaceutical industry-led clinical trials; (2) Phases of clinical trials, current Good Clinical Practices (GCP), International Council for Harmonisation of Technical Requirements (ICH), Food and Drug Administration (FDA), country clinical research law and guidelines, and Good Documentation Practices; (3) Experience in clinical trials covering at least 10 different therapeutic areas including oncology across a minimum of 10 clinical trials; (4) Experience in all types of study visits (Qualification, Initiation, Monitoring, Co-Monitoring, Termination, Site Motivational Visits) and clinical trial phases (Phase I, II, III); (5) Conducting at least 50-75 onsite/remote visits independently; (6) Simultaneously managing multiple studies (at least 3 studies) and multiple sites (5-10 sites); (7) Conducting study start-up activities in at least 3 studies, including: ICF Customization, Site Regulatory Package Customization and Submission, and Facilitation of execution of site contracts and agreements; (8) Using Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), Electronic Medical Records, Electronic Trial Master File Systems (eTMF), Interactive Web Response System (IWRS), and Safety Reporting Systems; and (9) Analytical/risk-based monitoring and analyzing site metrics and trends.

To apply, please send resume to openings@parexel.com and cite requisition number 00946, or apply at jobs.parexel.com.