RapidTrials

POSITION SUMMARY:

Unique opportunity for a qualified, experienced, and self-motivated Research Study Assistant (RSA) to work with a research site supporting a Phase 1 study of an investigational drug for the treatment of advanced solid tumors and advanced breast cancer. The primary assignment is to maintain timely, accurate electronic data capture (EDC) data entry and query resolution in accordance with the protocol, source documentation, and site requirements.

Position Type: Contractor/freelance position (no benefits included or expenses reimbursed)

Position Reports To: Research Institutions Data Manager

Duration of Contract: 15 weeks plus required inclusive of 2-3 weeks of site orientation/onboarding before full productivity

Hours: 16 hours per week

Location: Hybrid /New Brunswick, NJ

PRIMARY RESPONSIBILITIES:

Maintaining accurate, complete, and timely study data in the sponsor-designated EDC system.

• Abstracting protocol-required data from available source documentation and completing electronic case report forms (eCRFs).
• Reviewing, responding to, and resolving EDC queries promptly, including coordinating with appropriate Site study staff when source clarification is required.
• Maintaining assigned study data in an audit-ready state and escalating unresolved data issues to Data Manager or Site designee.
• Scope is limited to data entry and query resolution unless Site , CRO, or Sponsor agree in writing to expand the assignment.

ESSENTIAL JOB FUNCTIONS

Data Entry & Query Resolution

• Reviews available source documentation and enters protocol-required data into the sponsor-designated EDC system for assigned subjects and visits. 
• Escalates missing source documentation
• Maintains timely EDC data entry and keeps assigned eCRFs current in accordance with sponsor, CRO, site, and contractual timelines.
• Ensures EDC data are consistent with available source documentation and identifies missing, inconsistent, or incomplete data requiring clarification.
• Reviews and resolves EDC queries and requests for data clarification promptly and documents responses as required.
• Coordinates with appropriate Site personnel to obtain clarification or additional source information needed to complete data entry or close queries.
• Escalates unresolved data discrepancies, protocol-related data questions, or missing source information to Data Manager or Site designee.
• Maintains assigned study data in an audit-ready state and supports timely closure of outstanding data issues.
• Enters post audit data as instructed
• Performs assigned data activities in accordance with the protocol, GCP, Site procedures, and applicable sponsor/CRO requirements.

Administration / Communication

• Participates in required study teleconferences or data focused meetings as requested.
• Communicates promptly with Site study staff regarding outstanding EDC entries, data clarifications, and query resolution needs.
• Supports monitor or CRA to resolve data issues, and review activities, as requested, including follow-up on data discrepancies identified during monitoring.
• Working with CRA/monitor to s expected. F
• Reviews relevant monitoring follow-up items and resolves assigned outstanding data issues within required timelines.
• Identifies and promptly communicates data management issues or barriers that may affect timely study data completion.

SITE ONBOARDING & EDUCATION

• Complete Site -specific onboarding modules and role-specific training required for an RSA/contract resource.
• Obtain required system access, including EPIC and study/EDC access, before performing assigned work.
• Complete applicable Site employee-health screening requirements, including any required TB testing and vaccinations.
• Complete on-site EPIC training  
• Maintain required study and role-specific training throughout the assignment.

SKILLS & ABILITIES

• Excellent time management, prioritization, and organizational skills; ability to work independently, manage multiple data tasks, meet deadlines, and maintain strong attention to detail and accuracy.
• Strong written and verbal communication skills and the ability to communicate effectively with site staff, sponsor/CRO representatives, and monitors regarding data entry and query resolution.
• Strong command of English, including the ability to read and interpret clinical research source documentation, protocol requirements, and EDC queries while maintaining confidentiality.
• Ability to access and accurately enter data in electronic clinical trial databases and EDC systems.
• Ability to compile, reconcile, and review study data for completeness and consistency; proofread entries and query responses; troubleshoot discrepancies; and escalate issues appropriately.

REQUIREMENTS

• Bachelor's Degree; relevant clinical research experience may substitute for degree.
• At least five (5) years of clinical trial data coordination, clinical research coordination, or related experience.
• Working knowledge of clinical trials, applicable regulations, and IRB/ethics committee requirements.
• Certificate of completion for Good Clinical Practice (GCP)/International Council for Harmonisation (ICH) training.
• Certification in Human Subjects Protections (CITI) or equivalent training.
• Microsoft products, Internet, and general computer proficiency required.
• Experience with EDC and EMR systems required; Medidata RAVE and EPIC experience preferred.
• Experience supporting oncology studies, advanced solid tumor studies, or breast cancer studies, preferred.
• Able to work effectively as a clinical research team member with clear, timely written and verbal communication, including communicating data discrepancies, missing source information, and issues affecting data completion
• Able to work independently, prioritize appropriately, complete data entry and query resolution within required timelines, and demonstrate accuracy and attention to detail