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Category: Communications Jobs
Job Title: Program Coordinator, Scientific Communications
Location: California(US)
Job Type : Full Time
Brief Job Description: Responsible for reviewing online submissions of concepts for completeness; communicating needs for additional information to complete the submission process. Work closely with Medical Science Liaisons (MSLs), principal investigators and staff to ensure submission of all Investigator Initiated Study (IIS) related study documentation [Proposal, budget, protocol, Informed Consent Form (ICF), etc.] Independently coordinates and manages review of draft protocols, final protocols, amendments, ICFs, and investigator IND submissions Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues Responsible for sending IND Safety Reports on an as needed basis Initiates drug shipments and ensures that drug supplies are adequate for assigned studies Develops basic knowledge of the study contract, budget, and payment process including legal language and document structure as it impacts assigned studies Responsible for initiating and tracking site milestone payments Communicates status of trial to manager and team Partners with team members and other functional areas within Pharmacyclics such as Regulatory, Drug Safety, Legal, Clinical Sciences, Biometrics, and Research Oversees clinical trial study progression, including enrollment updates, invoice payments, and receipt of publications using the IST system database Contributes to the IST program financial management and provides projections for individual study milestone payments Independently manages interactions with external vendors Coordinate the review of submitted CTEP concepts as they are received as well as responsible for entering concepts into database based on approval Manage the agenda and provide approved minutes for review meetings and presentations, as required Utilizing knowledge of study protocol, responsible for keeping non-sponsored portfolio study schema slides updated Partner with other internal and partner groups to achieve deliverables Responsible for ongoing communication and collaboration with our partner, Janssen, on our shared study portfolio Identify and escalate site, vendor and study related issues, as appropriate Represent Medical Affairs externally to investigators and internally to Sr Management and partners Establish and manage project timelines Perform other duties as assigned


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