Qualifications

- Training (appropriate to anticipated duties — such as nursing degree or diploma, physician's assistant, study-specific training, in depth protocol understanding, other as applicable to assigned responsibilities).
- Certification (certification by one of the clinical research associations, i.e., SoCRA, ACRP) to be completed within two years of employment.
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including REB submissions, reporting and source documentation, handling dangerous biomedical goods, blood collection, trial management).
- A thorough understanding of applicable regulatory requirements, principles of ICH GCP (E.6) and biomedical research ethics.

Responsibility

Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.

Duties

- Develop management systems and prepare for study initiation:

- possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility

- review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol

- review the protocol summary sheet and the Informed Consent Form for accuracy and clarity

- develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity

- Utilize “all” resources made available for patient recruitment (ie. Other physician EMRs when access has been granted at regular intervals)

- ensure that the randomization procedure is followed as per protocol guidelines





- Patient binders must be prepped prior to visit (this includes all bloodwork, ECG interpretation reports, CXR, Spirometry results, physician communications, adverse event reports, etc. must all be printed and filed in the binders AND presented to PI prior to entering patient clinic room

- document protocol exemptions and deviations.

- ensure adherence to protocol requirements

- review laboratory data, inform investigator of abnormal values and document daily

- report to primary care provider as appropriate

- communicate with pharmacy staff to assure timely and accurate study drug distribution

- manage administration of investigational therapy

- maintain dispensing logs, maintain temperature logs for room, fridge, etc.

- maintain copies of any documentation for dispensing of investigational products and/or study-related supplies

- oversee specimen collection, storage and shipment

- attend study-related meetings as appropriate

- communicate regularly with the Principal Investigator, monitor (and others responsible for conduct of the research) about study-related issues

- Enter EDC on time

- Check for expired lab kits at regular intervals

- Participate in weekly team meetings

- Organize binders, signatures,



and pending items prior to monitoring visits

- Record data and study documentation:

- record data as directed using the appropriate media or platform

- follow procedures for access and security for electronic data entry

- review keyed data for accuracy, as needed

- send data to the data collection center on a timely basis

- maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports

- correct and edit data as directed and as appropriate.

- Monitor and report adverse events:

- assess, document and record all AEs as outlined in the protocol

- report serious AEs to the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).

- Regulatory documentation:

- know and understand all regulatory requirements associated with the conduct of the study assigned

- maintain files and documents as regulations dictate

- ensure that all required documentation is complete and appropriately filed.

- Management of site activities during audits and inspections:

- prepare for quality assurance audits and regulatory inspections, as needed

- act as contact person before, during and after audits and inspections

- provide all required documentation to auditors

- make all appropriate corrections as requested by auditors

- coordinate site response to audit/inspection findings.

Job Types : Full-time, Part-time

Benefits :

- In office parking

Schedule:

- 8 hour shift
- Monday to Friday
- Weekend availability

Work Location: In person

📌 Clinical Trial Coordinator/research Assistant (Niagara Falls)
🏢 Yrn
📍 Niagara Falls