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Clinical Research Coordinator

4 months ago

Raleigh, United States SiteBridge Research Inc Full time

SiteBridge Description:

Founded in 2021, SiteBridge Research is a community-focused integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on time and on budget, accelerating time to market and product adoption in communities that are the most vulnerable and the hardest to reach. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes. SiteBridge also helps with FDA diversity planning and building effective community engagement strategies.

Job Description: Clinical Research Coordinator - Contractor

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the Clinical Principal Investigator (PI) on multiple ongoing research studies. While the Principal Investigator is ultimately responsible for the clinical trial, the CRC is responsible for the facilitation and coordination of the daily clinical trial activities and plays a critical role in the conduct of the study. The CRC works collaboratively with the entire site team, sponsors, and clinical monitors to ensure ICH/GCP compliance, site productivity, and timely completion of studies. In addition, and most importantly, this role represents our mission and vision by focusing on the trusted physician/patient partnership from start to finish for every clinical trial conducted at the site and is key in transforming clinical research for every participant. The position will be responsible for specific clinical site activities to maintain the operational excellence required of clinical sites/staff involved in clinical studies and to assure compliance with protocol-specific procedures, data acquisition, and records management. This role will report to the Director, Clinical Research Coordinators and Project Managers.

The position is located in Raleigh, NC and will be required to be on-site.

This is a 1099 Independent Contractor role and is open full-time.

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

Qualifications & Required Experience:

* Requires Bachelor's degree (at minimum) in a relevant life science discipline; RN (BSN) is preferred; certification as CCRC/CCRP is a plus
* 2+ 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 bilingual, Spanish speaking candidates
* 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

Additional Qualifications:

* 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

Pay Range:

The combined pay range for this role is $28 - $36/hour. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.

SiteBridge Research, Inc. is proud to be an Equal Opportunity Employer providing employees with a work environment free of discrimination and harassment. We respect and seek to empower each individual and value the diverse cultures, perspectives, skills and experiences within our workforce. We celebrate diversity and do not discriminate based on race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability status, or any other applicable characteristics protected by law. All employment decisions at SiteBridge are based on business needs, job requirements and individual qualifications and performance.

JOB CODE: 24-0003