Insmed Incorporated

Senior Clinical Research Associate

ID
2019-1257
Job Function
Clinical Operations

Company Description

About Insmed!

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

 

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

 

Overview

About the role!

  • The Senior Clinical Research Associate (Sr. CRA) assists the Clinical study team in the day-to-day management and monitoring of site-level activities related to assigned projects and studies.

Responsibilities

Responsibilities:

 

• Work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms
(CRF) and other required documents for clinical research studies
• Contributes to the development, review and revision of study management (e.g. clinical monitoring plan,
communication plan, etc.) and vendor plan documents (e.g. laboratory manual, CRF completion guidelines, etc.)
• Work with Clinical Research Organizations (CRO) and study teams to write, review and revise Informed Consent
Forms (ICF)
• Works directly with Investigators and site personnel to collect, track and report on feasibility information related to
the identification, evaluation and selection of investigator sites
• Participates in the selection and management of CRO and other third-party vendors Participates in the development
and utilization of study training materials
• Conducts monitoring, co-monitoring and QC visits, as needed, including pre-study, initiation, routine monitoring and
close out visits to ensure data quality and integrity, as well as site adherence to ICH/GCP guidelines and regulatory
requirements
• Supports the management of the daily operations of clinical research studies to ensure timely start-up, accrual,
maintenance and close-out of assigned studies
• Manages and reports on investigator site and overall study progress, including review and approval of site
monitoring reports

• Monitors site investigational product needs and works with clinical supplies to ensure sites receive appropriate
supplies in a timely manner
• Works collaboratively with Scientist and project team to ensure ongoing review of patient profiles and data listings
• Works directly with the CRO to ensure review, revision and maintenance of study logs
• Attends study team meetings and writes, reviews and revises meeting agenda and minutes in collaboration with
CRO
• May lead team meetings if delegated by Clinical Project Manager
• Participates in the review of clinical trial agreements, work orders and other site/vendor agreements May assist in
the review and processing of invoices related to such study agreements
• May assist in the preparation of presentations and manuscripts for scientific meetings and technical journals
• Attends scientific meetings and profession courses/conferences, as appropriate
• Assists with the training and supervision of newly hired CRAs, as appropriate
• Assists with the development, review and revision of departmental SOPs and processes qualifications.

Qualifications

About You!

 

Qualifictions:

• Associate degree in a scientific/healthcare field; Bachelor's degree is preferred

 

Knowledge & experience:

• 5 years of experience in pharmaceutical clinical research and/or any sufficient combination of
education and training as deemed appropriate to fulfill the requirements of the position
• Extensive knowledge of ICH/GCP guidelines and regulatory requirements

 

Skills:

• Excellent computer and organizational/analytical skills
• Excellent communication skills (verbal and written).
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

 

Travel Requirement:

Ability to travel up to 25%, including overnight stays, as necessary

 

Other:

• Roll-up-your-sleeves orientation and a strong ability to work in a team-based environment
• Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence,
Accountability, Driven, Collaborative and Solutions; along with any other position specific
competencies.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally
diverse workplace.

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. This position is also bonus eligible.

 

Insmed is an Equal Opportunity Employer and will evaluate all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

 

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

 

Please note that we review every submission and we will keep all submissions on file for six months.

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