In PersonMay require travel to field sites and scientific meetings.
Biology & BiotechClinical Research Operations
About the job
Requirements
A PhD, PharmD, registered nurse qualification, Nurse Practitioner qualification, or Physician Assistant qualification is required.
At least 3 years of biotech experience in oncology, dermatology, or autoimmune disease.
Proficiency with Microsoft Office.
Ability to build effective working relationships internally and externally to achieve goals.
Ability to solve problems outside the immediate area of expertise.
Clear and concise verbal and written communication skills and strong organizational skills, with attention to detail.
Ability to work independently in an interdisciplinary, fast-paced, changing environment.
Responsibilities
Provide strategic input and development support for clinical plans and individual study protocols.
Write or assist in writing clinical plans, study protocols, and protocol amendments in close collaboration with the Vice President of Clinical Development.
Write or assist in writing Investigator Brochures, DSURs, and other regulatory documents.
Assist Clinical Development team members with clinical trial implementation and conduct, including reviewing enrollment packets, adverse events, and other clinical data generated during the trial.
Assist with Medical Monitor responsibilities.
Work closely with Data Management to ensure relevant clinical data is collected in a timely manner and assist with cleaning data listings.
Participate in developing clinical operating guides and maintain secure study files.
Review evaluation results with appropriate management before implementation.
Evaluate complex issues involving analysis of situations or data and exercise judgment in selecting methods, techniques, and evaluation criteria to obtain results.
Determine methods and procedures for new assignments.
May coordinate activities of other personnel as a team lead.
May travel to field sites and scientific meetings.
Desired Qualifications
Teamwork and collaboration skills.
Commitment to integrity, accountability, transparency, and drive.
Corvus Pharmaceuticals is a clinical and late-stage biopharmaceutical company developing novel therapies with the potential to significantly improve the treatment of immune diseases and cancer. Our lead program, soquelitinib, is a first-in-class, oral therapy that selectively inhibits ITK to modulate and control parallel signaling pathways in the immune system. We are a small innovative and collaborative biotech company looking for like minded individuals to help grow the company and career. We work on-site alongside our colleagues to help build collaboration.
ROLE AND RESPONSIBILITIES
Provides strategic input and development support for clinical plans and individual study protocols
Writes or assists in writing of clinical plans and study protocols and protocol amendments in close collaboration with VP, Clinical Development
Writes or assists in writing Investigator Brochures, DSURs and other regulatory documents Assist other team members in Clinical Development in the implementation and conduct of clinical trial which includes but not limited to review of enrollment packets, review of adverse events and all other clinical data generated during conduct of trial
Assist in Medical Monitor responsibilities
Work closely with Data Management to ensure that all relevant clinical data is collected in a timely manner and assist with cleaning of data listings
Participates in the development of clinical operating guides and m_aintains secure study files Reviews results of these evaluations with appropriate management prior to implementation
May require travel to field sites and scientific meetings
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
Determines methods and procedures on new assignments
May coordinate activities of other personnel (team lead)
QUALIFICATIONS AND EDUCATION REQUIREMENTS
PhD, PharmD, R.N, Nurse Practitioner or Physician Assistant required
3+ years of biotech experience (oncology, dermatology or autoimmune disease
PREFERRED SKILLS
Excellent teamwork and collaboration skills
Proficient with Microsoft Office.
Able to build effective working relationships throughout the organization internally and externally to achieve goals.
Flexibility and willingness to solve problems that fall outside of immediate area of expertise
Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
Work independently in an interdisciplinary, fast-paced, often changing environment.
Committed to the values of integrity, accountability, transparency, and drive.