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Clinical Trials Specialist

Aerotek

This is a Full-time position in Bernardsville, NJ posted December 13, 2019.

Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution.

Assigned to support the execution of one or more studies across a program.

Support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs).

Organizes and delivers reports and metrics Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings Collates data for assessments such as feasibility and site selection and reviews site usability database Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders Collates materials for training and investigator meetings Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance Ensures scheduled reports are received (i.e.

1572 re-portable changes, financial disclosure form) Communication with sites as directed and maintains site contact information Contributes to line listings review for Blind Data Review Meeting (BDRM) May manage or contribute to oversight of Third Party Vendors (TPV) Tracks and monitors close out activities
– study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives Proactively recommends process improvement initiatives for the department About Aerotek: We know that a company’s success starts with its employees.

We also know that an individual’s success starts with the right career opportunity.

As a Best of Staffing ® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees.

Since 1983, Aerotek has grown to become a leader in recruiting and staffing services.

With more than 250 non-franchised offices, Aerotek’s 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year.

Aerotek is an Allegis Group company, the global leader in talent solutions.

Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodationaerotek .com for other accommodation options.

However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting.

The Recruiter is the sole point of contact for questions about this position.