Clinical Trial Coordinator (CTC) - Summer Internship - United States
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- Our company is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives.
- Our purpose as a company is to discover and develop therapies that will change the course of human health.
- We value our passion for patients, quest for innovation, spirit of independence and love of challenge.
- With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The Clinical Trial Coordinator (CTC) is responsible for providing in-house support and assistance to assigned study teams and management staff.
Responsibilities will include, but are not limited to, the following:
- Support study teams in administrative tasks and logistics (i.e. expenses, travel arrangements, meeting set-up including investigator meetings)
- Manage study material and study supplies, as applicable
- Create and maintain Study Document Shared Locations for assigned study(ies) on the Central Repository
- File and maintain the study administrative files locally and send original documents to central TMF. When applicable, ensure electronic filing.
- Support Health Authority inspections and CQA audits as required
- Maintain and update data as appropriate in study management tools including CTMS, National Clinical Trial Databases, etc. as appropriate
- Assist with reconciliation of IP at study level in collaboration with IMSC
- Manage local translations and printing for required local documents
- Support contract implementation as required
- distribute documents to investigational sites, ECs, or vendors as per requirements and distribute communications and study documents to study teams.
- support the production, coordination, completeness and accuracy of IRB/EC submissions forin-sourced studies
Study Planning and Conduct:
- Assist with TMF set-up, ongoing quality review, and final reconciliation
- Assist with collection of appropriate country/site insurance
- Assist with management of study-level IP shipment to sites as necessary
- Support the development/coordination of study training materials
- Support the collection and tracking of study documentation as necessary
- Assist with compilation of Clinical Study Report appendices
- Assist with granting / removing systems and Sharepoint accesses
- Support the study specific training matrix
- Manage site file binders activities for in-sourced studies
Additional responsibilities may include, but are not limited to, the following:
- Provide general administrative and coordination support to the clinical operations department and the development and continuous improvement of departmental procedures.
- Organize/maintain administrative activities/systems to support department members including compiling, analysis, tracking, filing and other functions as required.
- Open, sort and distribute mail, fax documents, keep files, order office supplies and maintain supplies.
- Responsible for scheduling, organizing, and coordinating logistics for on- and off-site staff meetings.
- Responsible for logistics of meetings with internal and external partners, including scheduling meetings and hosting the visitors.
- Coordinate agenda for, schedule and organize (including conference dial in) meetings as required.
- Manage staff calendars, updating monthly schedule, and arrange travel itinerary and related activities.
- Prepare presentation materials.
- Schedule interviews for candidates.
- Conduct additional tasks as may be required by the Clinical Operations Leadership team.
- Expected duration of all summer internships will be from on or about June 1st and will go through August 31, 2017.
- Our internship positions are considered paid temporary positions. Housing assistance is not available or provided.
- Good written and oral communications skills with understanding of written and oral English
- Excellent organizational and administrative skills
- Self starter and proactive self learner
- Ability to multi-task effectively and prioritize assignments from multiple sources
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
- Experience supporting teams highly desirable.
- Responds flexibly to changing business demands and opportunities, proactively looking for ways tocontribute
- Uses different communication methods appropriately (e.g., email, voice mail, face-to-face)
- Learns from both successes and failures
- Continually works to improve products, services, and work processes
- Identifies and/or supports new solutions, opportunities, and initiatives
- Maintains high quality while meeting deadlines and commitments
- Hold self accountable for actions and results
- Ability to work with limited day to day supervision
- Ability to function productively in a fast paced and rapidly changing environment
- Able to resolve routine problems independently
- Works with team members to solve problems and escalate to management appropriately.
- Graduate and undergraduate student applicants should be actively enrolled and pursuing a degree from an accredited college and have valid U.S. work authorization.
- Our company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Our company complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for our company in the U.S.