Clinical Research Associate/Senior Clinical Research Associate

Clinical Research Associate/Senior Clinical Research Associate

About Edgewise Therapeutics

At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.

We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!

About the Position:

This is a remote position for a growing Clinical Development. The assigned clinical trials will be highly complex and high risk, e.g., multiple indications, data monitoring committees, interim analyses, adaptive design, requiring the coordination of multiple vendors, or other special assessments. Candidate may be asked to provide support to clinical study lead for more than one study or across programs.

Essential Job Duties and Functions:

• Accountable for study and site level tracking e.g., patient visits, invoices, and IRB submissions

• Supports patient enrollment activities and deliverables.

• Participate in country and site feasibility/selection process.

• Acts as QC of Trial Master Files; review of TMF index.

• Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings.

• Proactively identifies potential operational challenges and in collaboration with senior team members, provides solutions to ensure study execution remains on track.

• May participate in review of data listings to identify trends.

• Support the oversight of vendors at the direction of the study lead.

• Participation in the development of patients and site facing documents.

• Maintains internal Clinical Operations databases and document repositories.

• Assist with administration and management of site and vendor invoices, including invoice reconciliation for clinical trial operations.

• Assist with site start-up activities, e.g. essential document package review, site initiation slide decks

• Oversight of CRO monitoring activities (e.g., visit schedules, monitor visit reviews, reviewing monitoring plant.

• Review of relevant study-specific plans and/or processes, as applicable

• Document review and monitoring of risks and decisions at the study level and implementation of mitigation strategies.

• Participates in the review of database CRFs and user acceptance testing.

• Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and attending the inspections.

• Help with onboarding and mentoring of new department members.

• Adheres to Clinical Operations processes and SOPs.

• Read, understand, and comply with all workplace health and safety policies, safe work practices; and company policies and procedures.

• Perform other duties as assigned by supervisor.

Required Education, Experience and Skills:

• At least 2+ years of relevant experience and a BS or BA (Life Sciences)

• Clinical trial experience in the pharmaceutical or health care industry or equivalent

• Excellent attention to detail, verbal, written, interpersonal and presentation skills are required.

• Must be familiar with routine medical/scientific terminology.

• Proficiency with MS Office

• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.

• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision.

• High energy level, personal productivity, creativity, and commitment

• Team-player desiring to work in a fast-moving, dynamic start-up environment

Salary range: $75,000-$145,000, title and salary commensurate with experience

Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.

There is no deadline because the employer accepts applications on an ongoing basis.

Edgewise does not accept resumes from recruitment agencies for this position. Please do not send resumes to Edgewise employees or the company location. Edgewise is not responsible for any fees related to unsolicited resumes.