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Clinical Research Coordinator

$39 - $43 per hour

Actalent

Sr. Clinical Research Coordinator Job Description The Sr. Clinical Research Coordinator (CRC) plays a pivotal role in managing the Eosinophilic Gastrointestinal Diseases Program. This position requires overseeing a wide array of clinical research studies, including industry-sponsored, government-funded, and investigator-initiated projects. The ideal candidate will navigate these studies with minimal support, ensuring compliance and organizational standards are upheld from startup to closeout. This role demands a professional with significant experience in academic and sponsor environments, possessing strong regulatory knowledge and attention to detail. Responsibilities Independently manage a portfolio of studies across multiple funding sources, phases, and methodologies from startup through closeout. Prioritize daily, weekly, and long‑term workload across multiple active studies. Develop and maintain study timelines, milestone trackers, enrollment trackers, and operational workflows. Identify barriers to execution, operational risks, and proactively communicate issues and solutions to the Principal Investigator and appropriate stakeholders. Serve as the primary operational point of contact for investigators, sponsors, CROs, collaborators, and internal departments. Provide study status updates to the Principal Investigator and leadership regarding progress, risks, timelines, and resource needs as requested. Prepare and manage all IRB submissions, including initial applications, amendments, continuing reviews, reportable events, deviations, closures, and recruitment materials. Maintain accurate, complete, and inspection‑ready regulatory files and track approvals, expirations, and required submissions. Ensure studies are conducted in compliance with protocol requirements, GCP, institutional policy, and applicable regulations. Participate in sponsor meetings, feasibility assessments, monitor visits, and study startup discussions as appropriate. Independently lead participant recruitment through chart review, database screening, outreach, provider networking, and other strategic methods. Work with internal and external resources to design, improve, and execute recruitment plans for rare disease and specialty populations. Conduct eligibility screening and enroll qualified participants efficiently. Obtain informed consent and assent for adult and pediatric participants, including complex and interventional studies involving families and special populations. Build strong participant and family relationships to support retention and long‑term engagement. Coordinate and conduct research visits across outpatient, procedural, laboratory, and remote settings. Manage all visit logistics with participants and relevant departments, including scheduling, room readiness, supplies, protocol procedures, and required resources. Prepare visit packets, worksheets, CRFs, questionnaires, specimen kits, and source documents. Ensure protocol windows, follow‑up schedules, and visit requirements are met. Collect, organize, and maintain complete source documentation for Principal Investigator review and signature. Perform accurate and timely data entry in sponsor EDC systems and investigator‑led platforms such as REDCap, Excel, and internal databases. Perform detailed medical record abstraction and clinical data extraction for retrospective and prospective research studies. Coordinate biospecimen collection, processing, tracking, shipment, and documentation in accordance with protocol and institutional requirements. Resolve data queries, reconcile discrepancies, and maintain high data quality standards across all studies. Maintain study tools such as logs, trackers, manuals, source templates, workflows, SOPs, and operational systems to improve execution and consistency. Contribute to the development of research workflows, SOPs, templates, recruitment strategies, and operational systems to support a growing research program. Essential Skills Proficient in chart review, clinical research, regulatory processes, and IRB submissions. Strong skills in chart extraction and data management. Ability to independently manage and prioritize multiple studies and tasks. Additional Skills & Qualifications Bachelor's degree required. Experience in pediatrics is a plus. Work Environment This role is part of a clinical research team in a hybrid environment, involving both onsite and remote work. The position requires direct interaction with patients on investigator‑initiated and funded trials. The work setting is fast‑paced and demands a high degree of autonomy and initiative. Job Type & Location This is a Contract position based out of NewYork,NY. Pay and Benefits The pay range for this position is $39.00 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Application Deadline This position is anticipated to close on Jul10,2026. Equal Opportunity Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Accommodation Statement If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. SanFrancisco Fair Chance Ordinance Pursuant to the SanFrancisco Fair Chance Ordinance, for all positions located in the city and county of SanFrancisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Artificial Intelligence (AI) Usage Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr

Vacancy posted 2 days ago
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