Clinical Site Specialist

Job type:
Start date:
18 months
Real Staffing
Kansas City
Published at:
flag_no USA
Project ID:

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Specific Job Duties:

Provide overall support for project(s) as directed by Project Manager(s)

Working knowledge of protocol(s), processes, and requirements for assigned project(s)

Contact potential investigator sites in accordance with the project specific feasibility process to determine site interest

Assure timely entry of feasibility results in UBCTrack and/or applicable tracking mechanism (e.g. supporting Excel file(s))

Call to recruit prospective investigator sites in accordance with the project specific recruitment plan. Resolve any missing or incomplete entries within UBCTrack

Prepare and forward regulatory document packets and simplified site contracts to investigators sites

Receive and review/process completed regulatory documents and completed simplified site contracts from investigators and forward to the Regulatory Document Specialist (RDS) for final review

Ensure timely entry of site contact and status of regulatory documents and simplified contracts in UBCTrack or other project specific tracking databases.

Contact the site regarding any follow up issues that are identified by the RDS and update UBCTrack accordingly

Contact with the investigator sites via i.e., phone, written, email, or otherwise as outlined in the protocol or other project guidance documents

Receive and review Data Collection Tools (case report forms) for completeness, accuracy, and legibility and for possible Serious Adverse Events (SAEs) that may have been recorded

Assure prompt notification to the safety group if a SAE is identified

Provide site management activities for assigned sites that may include, but are not limited to:

Proactive contact of sites to discuss study progress

Track subject enrollment status

Track subject adherence to study visit schedule

Resolve queries with sites

Track drug/study supply inventory and process resupply

Process investigator payments

Inquire regarding potential SAEs that may not have been previously reported

Address/follow up with any questions or issues

Attend study team teleconferences and provide updates, as necessary

Assist with/maintain study and Trial Master Files

Attend study team meetings and provide updates, as necessary

Attend investigator meetings and provide support, as needed

Copy regulatory files for closeout visits as needed

For non-monitored studies, may be responsible for training site personnel and/or ensuring site personnel complete required training (i.e. web-based, Investigator Meeting, etc.)

Other duties as assigned by the Project Manager and/or CSS/Regulatory Document Manager and as determined by project/UBC specific SOPs.

Conduct specific monitoring visit phone calls and complete the requisite trip reports according to established guidelines per Sponsor approval