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SiteBridge Research, Inc. · 4 months ago

Clinical Research Coordinator - Dutchess County, NY - Part-TIme

Hyde Park, NY

Full-time, Part-time

Onsite

Entry Level

$28/hr - $36/hr

1+ years exp

SiteBridge Research, Inc. is a community-focused integrated research organization that builds a national network to deliver clinical research in underserved communities. The Clinical Research Coordinator will facilitate and coordinate daily clinical trial activities, ensuring compliance with regulations and supporting the Principal Investigator in the conduct of studies.

Research

Responsibilities

Ensure clinical study compliance with local and federal laws and regulations according to ICH/GCP Guidelines

Ensure study feasibility assessments for contracted sponsor-initiated studies

Assist the Clinical/Site Ops Leads on the set-up/start-up of research site to prepare for start-up and conduct of clinical trials

Lead oversight of pre-study, site initiation, and close-out visits with sponsor or CRO

Consult with Site Leads, sponsor, and CRO to determine the best recruitment practices for site and trials

Track study activities to ensure compliance with standard operating procedures (SOPs), protocols, and all related local, state, and national regulatory and institutional policies

Arrange screening and recruitment of potential study participants by scheduling visits to establish Informed Consent and perform intake assessments according to protocols

Create and maintain all essential documents and records related to the study

Act as a point of reference for study participants by answering questions and keeping them informed on the study’s progress

Oversee and/or manage the inventory of equipment and supplies related to the study, including documentation, reporting of issues, and ordering clinical supplies as needed

Communicate with laboratories and clinical investigators to ensure review and reporting of lab results and other clinical testing results

Direct the request, collection, labeling, storage, or shipment of interventional products

Ensure collection of specimens, questionnaire information, and input of data and patient information into electronic clinical systems

Monitor the enrollment status of participants at the site for each specific clinical study

Operate as primary contact for sponsors/CROs to schedule and coordinate site visits and answer queries

Participate in meetings (Investigator Meetings, Site Trainings, etc.) and seminars to update knowledge of clinical research and related issues

Prepare or participate in quality assurance audits and inspections performed by sponsors/CROs, regulatory authorities, or exclusively designated review groups

Provide regular updates to Site Clinical Investigator(s) and Clinical/Site Ops Leads on study progress related to recruitment, compliance, and other study-related matters

Qualification

Clinical research experienceFDA & ICH GCP knowledgePediatric experienceCCRC/CCRP certificationProject management skillsMedical terminologyDetail-orientedCommunication skillsTeam collaborationTime management skills

Required

Candidates with pediatric experience strongly encouraged to apply

Bachelor's degree in a relevant life science discipline is preferred; LPN/RN is preferred; certification as CCRC/CCRP is a plus; Education requirement exceptions can be made based on relevant clinical research experience

Minimum 1 year of experience in clinical research. Number of years of previous experience working in a clinical research setting; number of years of clinical site/trials experience will determine position level

Excellent working knowledge of FDA & ICH GCP regulations and guidelines is required

Strong preference for experience with late-phase and observational clinical research

Managing necessary clinical study and staff records related to clinical study activities including: case report forms, drug dispensation records, etc

Preparing advertising and other educational materials and conducting campaigns to recruit and enroll subjects

Preparing trial-related document support such as protocol worksheets, adverse event reports, IRB documents, procedural manuals, and progress reports

Experience identifying, reviewing, and reporting adverse events, protocol deviations, or other unanticipated problems appropriately to investigators and/or regulatory agencies

Assessing risk factors in study protocols such as sample collection procedures, data management issues, and possible subject threats

Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are preferred

Detail-oriented and meticulous in all aspects of work

Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative

Superior organizational and time management skills

Capable of working independently with minimal supervision and as part of a team

Understanding of medical terminology as well as standard clinical procedures and protocol

Ability to lift approximately 20 pounds for a short period and capable of standing for extended periods of time

Preferred

Strong Project Management skills including risk assessment and contingency planning

High level of collaboration, customer-oriented awareness, and focus

Skilled with standard computer programs including the MS Office suite

Strong interpersonal and written and verbal communication skills

Therapeutic experience in alignment with primary protocol(s) and site practice preferred

Some travel may be required

Company

SiteBridge Research, Inc.

Building bridges to reach further and empower more physicians and patients to take part in clinical research and improve health outcomes in the communities that need them the most #SiteBridgeResearch #BuildingBridges

Founded in 2021

Chapel Hill, North Carolina, USA

2-10 employees