The Sr. Clinical Research Associate provides support for clinical trials, including protocol preparation, site evaluations, study monitoring, and report generation.
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
- Participate and assist in design and preparation of protocols and case report forms.
- Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
- Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
- Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
- Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
- Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
- Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
- Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
- Assist with the maintenance of clinical archive and electronic files.
- Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BA, BS, RN, BSN or equivalent
- Basic knowledge and adherence to GCPs
- 5+ years of clinical research experience
- Strong attention to detail
- Ability to multi-task
- Unquestionable integrity and highest ethical standards
- Excellent written and verbal communication skills
- Self-motivated, assertive, and driven
Similar Jobs
Pharmaceutical
Conducts oncology clinical trial site management, monitoring, activation, routine visits, and close-out activities. Ensures compliance with protocols, ICH/GCP, FDA regulations, sponsor standards, and patient-safety requirements. Manages investigator relationships, recruitment, adverse-event follow-up, investigational product accountability, data queries, documentation, protocol deviations, and CAPA remediation. Partners with study teams, vendors, and site personnel, supports audits and inspections, and may mentor Clinical Research Associates.
Top Skills:
Electronic Monitoring SystemsFda RegulationsIch/GcpStandard Operating Procedures (Sops)Trial Master File (Tmf)
Biotech
Perform onsite and remote clinical site monitoring (PSV, SIV, IMV, COV), ensure protocol and regulatory adherence, manage study documentation and audit readiness, mentor junior staff, support site selection and RFPs, and contribute to clinical operations and SOP development across multiple protocols with significant travel.
Top Skills:
EdcMS Office
Healthtech • Biotech • Pharmaceutical • Manufacturing
Manage and monitor oncology clinical trials ensuring compliance with ICH GCP and local regulations. Perform site qualification, startup, monitoring (on-site/remote), source data verification, SAE reporting, IP accountability, document reconciliation, and trial tracking. Provide leadership, act as subject matter expert, escalate and resolve site issues, and support feasibility, site selection, and contract/budget activities.
What you need to know about the NYC Tech Scene
As the undisputed financial capital of the world, New York City is an epicenter of startup funding activity. The city has a thriving fintech scene and is a major player in verticals ranging from AI to biotech, cybersecurity and digital media. It also has universities like NYU, Columbia and Cornell Tech attracting students and researchers from across the globe, providing the ecosystem with a constant influx of world-class talent. And its East Coast location and three international airports make it a perfect spot for European companies establishing a foothold in the United States.
Key Facts About NYC Tech
- Number of Tech Workers: 549,200; 6% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Capgemini, Bloomberg, IBM, Spotify
- Key Industries: Artificial intelligence, Fintech
- Funding Landscape: $25.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Greycroft, Thrive Capital, Union Square Ventures, FirstMark Capital, Tiger Global Management, Tribeca Venture Partners, Insight Partners, Two Sigma Ventures
- Research Centers and Universities: Columbia University, New York University, Fordham University, CUNY, AI Now Institute, Flatiron Institute, C.N. Yang Institute for Theoretical Physics, NASA Space Radiation Laboratory
