Ref #: 25880

Employment type: Permanent - Full-Time

Location: US - MD - Gaithersburg

Posted: 05-Jan-2021

Description

WHO WE ARE:

At DOCS, we care about our people and their passion, as they are the key to our success and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term career. We have over 4500 employees globally working on novel therapies that deliver real impact to patients in need.

All our team members have the independence to get the job done and support from the experienced leadership team when you need it. If you want a career with a difference, DOCS is the place for you.


JOB SUMMARY:

The Study Coordinator (SC) provides administrative study/project related support for the Delivery Team, coordinating activities that ensure quality and consistency across the portfolio. The position requires an individual who works independently and in a team environment and who is experienced in processing clinical study research documents. Position requires collaboration, ability to effectively manage multiple tasks and assignments simultaneously and excellent communication and IT skills with other internal functional areas and external contracted sites. The SC will be assigned a portfolio of Externally Sponsored Research Studies (ESR)/Early Access Programs (EAP) to carry out the following tasks

PRIMARY RESPONSIBILITIES:

• Provide administrative support towards the review of ESR submissions that
enables timely and consistent approach to evaluation
• Support achieving quality and accuracy of data within the ESR registry and
management tool (Evidence Connect) daily and completeness of
documentation to enable teams to make effective business decisions
• Manage effective collaboration with internal stakeholders such as the
Delivery Director (DD), Medical Affairs Leader (MAL) and other internal
functions.
• Lead the administrative support of key governing bodies (GREG) and other
relevant meetings, ensuring efficient execution of the meeting and creation
of documented evidence of decisions, actions and participation
• Lead the collection, review and tracking of Essential Documentation, key
correspondence and other relevant study documentation ensuring storage,
formatting and version control is compliant with Company Procedures,
document retention guidelines, industry standards and the applicable laws
• Interface with Strategic Partners and other Contract Research
Organizations (CROs) & External Service Providers (ESPs) as well as internal
cross-functional teams to complete activities relating to the ESR processes
& systems
• Set-up, ongoing maintenance and closure of all study related Company
tracking systems and communication tools (i.e. Evidence Connect,
SharePoint, collaborative study folders on BOX) ensuring the Company
compliance requirements are met.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.