Clinical Trials Assistant (Contract)

BioCryst Pharmaceuticals

Posted on: April 17, 2021

Closing: May 17, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. Oral, once-daily ORLADEYO™ (berotralstat) is approved in the United States and Japan for the prevention of HAE attacks in adults and pediatric patients 12 years and older, and under regulatory review for approval in the European Union. BioCryst has several ongoing development programs including, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, and Korea. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company’s website at www.biocryst.com.

 

JOB SUMMARY:

The Clinical Trials Assistant will have experience in personnel assistance, organization, institutional and professional planning in a pharmaceutical setting and will work closely with clinical development teams in meeting company goals. This position will be responsible for supporting and ensuring efficient and productive clinical operations for BioCryst.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Participate in clinical trial team meetings and/or other trial-related meetings as appropriate.
• Prepare and distribute meeting agendas and minutes as required.
• Draft and/or assist with the preparation of trial-related documents, tools and templates, including newsletters.
• Create and maintain designated trial tracking systems such as the Clinical Trial Management System, site numbering allocation, site information files.
• Assemble, track and/or review regulatory packages for trial-related submissions to Regulatory Authorities and IRB/IECs or drug release.
• Set-up, maintain and manage trial master file and review trial master file contents.
• Set-up, manage and maintain investigator site file contents.
• Manage study supply shipment and tracking (lab kits, electronic diaries, advertisements).
• All other duties as assigned.

 

EXPERIENCE & QUALIFICATIONS:

• Administrative experience with a minimum of 2 years of pharmaceutical development experience gained ideally in a Sponsor and/or CRO role or an equivalent combination of education and experience.
• Hands-on experience with supporting more than one clinical program.
• Knowledge of the pharmaceutical business, clinical trial planning and conduct.
• Strong organization and interpersonal skills and the ability to manage and cultivate relationships.
• Ability to communicate effectively internally and externally.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

BioCryst Pharmaceuticals

Posted on: April 17, 2021

Closing: May 17, 2021

Salary($): Undisclosed

Position Type: Full Time

Similar Jobs


Cambridge, United States

Associate Director, Clinical Operations

As Associate Director, Clinical Operations, you will be accountable for ...

Redwood City, United States

Director, Regulatory Affairs

Revolution Medicines is a clinical-stage precision oncology company focu...

Redwood City, United States

Clinical Program Manager/Senior Clinical Program...

Revolution Medicines is a clinical-stage precision oncology company focu...

South San Francisco, United States

Senior CRA

Pliant Therapeutics is a public, clinical stage biopharmaceutical compan...