Job Title Rheumatology Review Group (RRG) Eligibility Liaison Duration:12 months Location: Giralda Farms
Division R&D / Global Drug Development Functional Area Description: The RRG Eligibility Liaison (REL) employs scientific and technical expertise to track, coordinate and enforce the timely delivery of quality clinical/study data.
Position Summary /Objective • Responsible for ensuring site participants in screening are ready for RRG review through site communication and clinical/study data coordination and tracking. • Manage communication of participant status with the RRG via email and REL progress tracker. Position Responsibilities • Completes training and remains current with RRG processes to respond to a site’s questions related to Screening Eligibility • Work closely with the sites to ensure completion of all activities within 15 days from the screening visit and contact the country specific CTMs for support if required. • Oversees and tracks site screening activities in the REL Progress tracker to ensure completion of lab results, data entry and query resolutions within the 28-day screening timeline. • Reviews lab data to determine if lab retests may be required and/or any exclusionary labs are present; contacts sites/CTM/lab/RRG as needed. • Liaises with GTM and CTMs as needed to prompt site responsiveness. • Determines when participants are ready for RRG eligibility review and notifies the RRG. • Works with sites and CTMs (when needed) to enable timely resolution of RRG queries. • Tracks RRG Eligibility eCRF queries to resolution; issues re-queries as needed. • Communicates with sites throughout the RRG eligibility review process to ensure timely decisions can be made (including but not limited to communication regarding status of lab results, RRG queries, disagreement with RRG decisions, etc.). • Facilitates email communication between sites and the Lead RRG Coordinator and RRG Lead Reviewer. • Facilitates virtual meetings between sites and the RRG and/or Efficacy and Eligibility Adjudication Committee when necessary.
Degree Requirements • Bachelor’s degree preferred Experience Requirements • 2 to 5 years of experience in clinical research or equivalent (industry, academic or study site experience is acceptable) • Proficient knowledge of GCP/ICH, drug development process and clinical trial operations.
Key Competency and Requirements • Extensive proficiency in Microsoft Office software and Electronic Data Capture (e.g., RAVE) • Must have strong interpersonal skills, be a team player and be willing to work in an environment where individual initiative and accountability to the team are required. • Excellent verbal, written and communication skills. • Detail-oriented with a commitment to quality. • Proficient in medical terminology with the ability to assimilate technical information quickly. • Proficient knowledge of the disease area(s) is preferred • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism. • Proficient planning/project management skills. Travel Required No travel required.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $48.00/hr.
