Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment.

Founded in 1992, Cubist is headquartered in Lexington, MA. The in-house Clinical Research Associate (CRA) position is one of demonstrated expertise in understanding and managing clinical study documentation.

Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required.

  A broad understanding of essential study documentation is critical.The in-house CRA is a key participant in the start-up, implementation, management and close-out of clinical trials; preparation of clinical study protocols; clinical study reports; INDs and New Drug Applications.The in-house CRA is involved in the review and is responsible for the tracking and filing of all critical study documentation.

  Additionally, the in-house CRA works closely with the Clinical Trial Manager (CTM) and Clinical Project Team to support various aspects of a Clinical Trial.

Duties and Responsibilities: Trial Master File and Clinical Trial Management Systems (CTMS) Maintenance: Responsible for oversight and maintenance of Central Files: Ensures adequate set-up of Trial Master File (TMF), proper and timely filing of all relevant study documents and standardized filing across all studies; performs routine interim and final TMF audits to ensure compliance with applicable work instructions, SOPs and ICH GCP guidelines.

Performs routine evaluation of filing procedures to ensure adherence to current guidelines at all times.

Responsible for study specific CTMS data management (CTMS).

Regularly obtains all necessary information from CROs, CTMs, CRAs and through meetings to ensure that trial specific information is current and complete.

Clinical Study Documentation: Responsible for editing and formatting of Protocols and Reports and assists in the design and development of case report forms and creation of study-specific Informed Consent Compiles documentation for Institutional Review Board submissions Generates Investigator Statements (Form 1572) and Financial Disclosure Forms Collects through direct communication with clinical sites or via CRO, ‘regulatory package’ and performs initial review of the ‘regulatory package’ for authorization of drug shipment per SOPCommunicates with CROs and/or study sites to support accurate completion, retrieval and review of all regulatory documents and site status/contact informationKey role in the review and/or writing of study newsletters Generates and maintains study checklists as necessary and keeps accurate records of all essential study documentsCoordinates the approval process of critical documents (protocol, CSR, etc)Interacts with CRO to define guidelines and terms for study-specific documentation filing and shipmentsResponsible for Informed Consent Review General Study Responsibilities: Assists in the development of timelines and budgets; keeps track of details within a clinical study necessary to ensure that budget information is current and timelines are metEnsures tracking and timely payment of invoices; may oversee and manage Investigator paymentsPlays key role in the review of study specific data review, including tables, listings and graphsKnows the stage of all study activities and communicates details to ensure that all team members are kept informed and aware of action items that will impact their tasksActs as liaison between different ancillary groups (e.

g., technical reviewers, copy center) in the creation of documents when communicating with resource providers outside the project teamPlans and organizes study related meetings; takes detailed notes at meetings on decisions and action items and distributes the list to the team in the form of minutesSupports CTMs and Clinical Research Associates (CRAs) in activities for which assistance is neededOther Responsibilities: Key role in training of new Clinical Documentation SpecialistsResponsible for training other members of Clinical Development in standard processesParticipate in the development and review of SOPs, guidelines, work instructions and Periodic travel may exceed 50% at timesRequired Skills: Proficiency in Microsoft Word and Excel required; Powerpoint and Database experience desirableKnowledge of the infrastructure and operations characteristics of CROs and centralized servicesAbility to foster relationships with vendors, clinical sites and colleaguesThe ability to support several projects simultaneously, a flexible working style and attention to detail are essentialRequired Experience: At least 2-3 years relevant industry experience in clinical research environmentPhysical Demands: N/ATo perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above.

  Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions.

  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 Total Rewards: Our outstanding total rewards package includes: competitive base salary; annual incentive plan with payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; 12 paid holidays, 4 of which are floating; 3 weeks vacation; flexible work schedules; comprehensive reward and recognition program.

Application instructions: We encourage you to apply to Cubist by applying directly at: http://hostedjobs.

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com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=216665&company_id=15975&jobboardid=24 Submitting a resume online at a job site could cause valuable screening information to be missed.

We are an Equal Opportunity Employer.

Note to Recruiters: Relationships with professional recruiters are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors.

We are also interested in establishing new relationships with experienced life science recruiters.

In order to recruit on Cubists behalf, each recruiting firm needs to have a written contract in place and agree to present candidates directly to Human Resources.

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