Clinical Research Coordinator - Germantown, WI - Part-Time

SiteBridge Research Inc•Germantown, WI

42d•$28 - $36•Onsite

About The Position

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 Site Development Operations and Study Management.

Requirements

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
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
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
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

Nice To Haves

Candidates with pediatric experience strongly encouraged to apply.
Strong preference for experience with late-phase and observational clinical research
Clinical and laboratory skills, including the ability to perform phlebotomy and process samples are 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

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