• Acts as the clinical site’s main point of contact accountable for quality and delivery during the pre-site initiation visit/start-up phase. • Manages country specific feasibility, and site pre-qualification and qualification activities. Configures, distributes, collects, reviews, and approves country and site-specific documents and essential regulatory documents. • Prepares and submits IRB/EC submissions in accordance with country/regulatory/client requirements. • Assists with forecast, development, and management of plans and strategies for site activation, patient recruitment & retention. • Supports protocol amendments throughout the life of the study as required. Maintains a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, SOPs, Sponsor training requirements and study specific procedures, plans and training. • Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required. • Works independently and manages multiple priorities to achieve project timelines. Uses site management experience and understanding of clinical trials methodology to demonstrate leadership and problem solving. Uses substantial site start up experience and strong understanding of clinical trials methodology to demonstrate team leadership within start up. • Takes initiative to drive quality, and deliverables across study team, facilitating team calls and supporting Clinical Operations Lead throughout start up. • Acts as mentor and start-up lead as necessary.

• Tasked to manage the remote start-up team to drive sites towards initiation • Oversee country-wide status of submissions and approvals for both local and central IRBs/ECs • Provide oversight on essential site document collection for regulatory package review and approval • Drive and coordinate the country level initiation strategy • Identify start-up trends and issues and develop resolution plan

Perform remote clinical monitoring tasks for designated projects in accordance with relevant SOPs and regulations. Conduct outbound calls to review recruitment plan and enrollment updates, check on site staff assignment, assess drug/study supply status, request outstanding documents, review site payment status, follow-up on outstanding dataResponsibilities include supporting clinical monitoring activities remotely, including collating regulatory documentation, drug / supply management and data collection. Update all relevant tracking system on an ongoing basis, act as the in-house site support, receive inbound calls and address issues based on experience either directly or inform appropriate team member, collect regulatory documents in collaboration with CRA and CTS as needed, complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.)

Selected for Super User (SU) role from over 150 applicants to be functional expert in new Clinical Research Services (CRS) support model. In this new global model, CRS end-users, such as Monitors, Clinical Trial Specialists, Clinical Operations Leaders and Project Leadership from all regions can reach out to a Super User with questions on any process, interface or system.•Extensive knowledge of all phases of the clinical trial lifecycle, from study startup (SSU) to in-house monitoring study maintenance and close out•Strong working knowledge of ICH-GCP Guidelines, regulatory requirements, PAREXEL SOPs, process guidelines, and work instructions •Supports all clinical processes and the following systems: Impact Harmony, PMED, Site Start Up, Safety Information System, STAR, TARGET tool, as well as MySites and EDC. •Experience includes a thorough understanding of business processes for the roles supported and how the systems are used by those roles•Present process and system updates and clarifications during monthly clinical meetings•Serve on assigned System related Change Management Committees / Steering Committees, and Advisory Boards•Serve on implementation teams for new system versions and process improvement initiatives, providing user view point for system configuration, feasibility assessments, brainstorming and other activities required by the implementation team•Execute User Acceptance Tests (UATs) for system upgrades•Deliver system presentations in response to client or internal requests•Schedule, coordinate, manage and lead end-user forum meetings

Perform remote clinical monitoring tasks for designated projects in accordance with relevant SOPs and regulations. Conduct outbound calls to review recruitment plan and enrollment updates, check on site staff assignment, assess drug/study supply status, request outstanding documents, review site payment status, follow-up on outstanding dataResponsibilities include supporting clinical monitoring activities remotely, including collating regulatory documentation, drug / supply management and data collection. Update all relevant tracking system on an ongoing basis, act as the in-house site support, receive inbound calls and address issues based on experience either directly or inform appropriate team member, collect regulatory documents in collaboration with CRA and CTS as needed, complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.)

Perform remote clinical monitoring tasks for designated projects in accordance with relevant SOPs and regulations. Conduct outbound calls to review recruitment plan and enrollment updates, check on site staff assignment, assess drug/study supply status, request outstanding documents, review site payment status, follow-up on outstanding dataResponsibilities include supporting clinical monitoring activities remotely, including collating regulatory documentation, drug / supply management and data collection. Update all relevant tracking system on an ongoing basis, act as the in-house site support, receive inbound calls and address issues based on experience either directly or inform appropriate team member, collect regulatory documents in collaboration with CRA and CTS as needed, complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.)

Project assistants work as one of the main points of contact between the client and Clinical Research Organization. Responsibilities include creating and maintaining various documents and trackers, processing payments, hosting and documenting both internal and client meetings. The project assistant is also in charge of processing the various access requests necessary for running a successful clinical trial.

The role of the institutional contactor is to build relationships between post-secondary schools and the US Department of Education in order to successfully complete research studies. Collected and compiled data on a student financial aid study.