Clinical Operations Coordinator

Job Responsibilities

• Assists the clinical operations team in the operational management and oversight of

clinical trials, during set-up, conduct and until archiving, for an assigned trial

• Coordinate the preparation and/or review of all operational trial-related documents

(e.g., forms, guidelines)

• Coordinate the preparations and/or review of site related documents (e.g.,

Investigator Site Files (ISF)

• Coordinate the preparation and distribution of the clinical study documentation (e.g.,

site communication, newsletters, pocket brochures, appendix 16 for the Clinical Study

Report (CSR))

• Coordinate the delivery and inventory of study related non-clinical supplies (ordering,

distribution, tracking, expiry dates management, resupplies)

• Coordinate site contracts finalization and execution

• Coordinate Insurance certificates for the trial in collaboration with legal department

• Ensure completeness and maintenance of key trial information in the Clinical Trial

Management System (CTMS)

• File and upload documents in the different systems as needed

• Ensure accurate maintenance and archiving of the electronic Master File (eTMF)

within the required timelines and contribute by performing ongoing quality

checks/review

• Function as a Study Owner in the eTMF when required

• Assist in reviewing and providing feedback of Standard Operations Procedures

(SOPs), Working Instructions (WISs) and processes

• Schedule and organize functional group meetings and/or events as needed

• Support the Clinical Trial Teams, including the Global Strategic Sourcing Group as

needed (e.g. Issuing of confidentiality agreements (CDAs), contracts execution and

shipment, issuing of change orders, Resource Request management, coordination of

the providers contracts, processing of invoices in the system)

• Perform other duties as assigned

Candidate’s Requirements:

• Minimum 2 years of clinical research experience is preferred

• Strong English written and verbal skills

• Ability to work independently

• Ability to effectively handle multiple priorities in a fast-paced environment

• Ability to find effective solutions when faced with difficult situations and to implement

team decisions

• Strong computer skills, including proficiency in Microsoft (MS)-based applications

(e.g., Word, Excel, and PowerPoint)

• Some overnight travel (<10%) may be required

Behavioral Skills:

• Results-driven

• Team player, ability to take initiatives

• Detail-oriented and quality conscious

• Strong organizational skills

• Time management skills

• Ability to work as an effective team member