FSP Senior Clinical Research Associate (Contract)

Essential Functions:

• Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.
• Ex-US: May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities
• .

Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirement

• s.

Review source document and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issu

• es.

Manage, prepare, send, track, and return investigational supplies as assigned. Includes monitoring and documenting investigational supplies dispensing, inventory, and reconciliat

• ion.

Monitor assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirem

• ents.

Review and oversee regulatory documentations for accuracy and completeness and support assigned clinical sites with any regulatory concerns as approp

• riate.

Communicate with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities as as

• signed.

Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinica

• l trial.

Other duties as

assigned.
Necessary Skills and

• Abilities:

Excellent verbal, written communication skills and interpersonal and presentation skills ar

• e required.

Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentatio

• ns required.

Electronic data capture (EDC), CTMS, IVRS, and eTMF experie

• nce required.

Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of cl

• inical trials.

Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minim

• al supervision.

Must be able to offer solutions when obstacles are identified and train as necessary to achiev

• e project goals.

Must have a general understanding of routine project goals from an organizati

• onal perspective.

Strong organizational skills and attention to details required. Ability to prioritize and plan work

load is essential.
Educat

• ional Requirements:

Bachelor's degree or equivalent combination of educa

tion and experience.
Exp

• erience Requirements:

> 5 years of experience as a Clini

cal Research Associate.