$80K — $100K *
OBJECTIVES OF THE POSITION:
Working closely with the Clinical Management, the Clinical Research Associate will manage the coordination of clinical collaborations and support clinical trials from protocol concept through the clinical study report. This includes ensuring essential activities related to study execution are completed including preparation of protocols, Case Report Forms, timelines, budgets and the provision of clinical trial materials. This person will also provide clinical data management support and support administrative tasks for the department.
Assist in creating and writing clinical trial protocols.
Identify, evaluate and establish trial sites, and closing sites down on completion of trial.
Train site staff on the protocol requirements, proper source documentation and case report form completion.
Order, track, and manage trial materials.
Conduct regular site visits, coordinate project meetings and write visit reports.
Implement action plans for sites not meeting expectations.
Manage and submit IRB documentation.
Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
Ensure the smooth running of the clinical research department protocols by managing the systems to track projects including all study, investigator and ethical review board information, patient recruitment activity, and financial management.
Help prepare study-related documentation; provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, etc.
Maintain the Trial Master Files (TMF) including: all essential documentation including but not limited to, ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents; clinical trial material shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all investigator and site correspondence; and schedules of payment.
Daily interaction with study Medical Director and members of the cross-functional study team; lead the Cross-Functional Study Team as needed; frequent cross-functional interactions with internal and external personnel (e.g., Regulatory Affairs, investigators, CROs, vendors, etc.).
Other duties as assigned.
COMPETENCY OR POSITION REQUIREMENTS:
Knowledge of FDA regulations and their practical implementation.
Knowledge of ICH GCP guidelines and regulatory requirements for clinical trial management.
Strong verbal and written communication skills.
Proficient computer skills.
Proficient with Microsoft Office Word, Excel and Power Point.
Ability to manage and prioritize workload effectively.
Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
Valid driver’s license, proficient driving skills, own reliable transport and up-to-date car insurance.
EDUCATION AND EXPERIENCE:
Bachelor’s degree or equivalent combination of education/experience in science or health-related field required
2-years field monitoring experience in clinical trails
Pulmonology and/or Oncology experience
Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Valid through: 6/21/2021
$100K — $150K *
2 days ago