Objectives:Under the supervision of the Director, Clinical Operations / Sr. Clinical Trial Manager, responsible for supporting the implementation, conduct and closeout of clinical studies to ensure that they are conducted according to the Investigational Plan and all applicable regulations.
Responsibilities:- Collaborates and supports CTM/Sr. CTM on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection, Trial Master File structure and preparation, and communication with clinical trial sites regarding administrative documentation, support materials and training
- Supports CTM/Sr. CTM and clinical operations team to ensure compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all clinical investigations and post-market studies
- Supports CTM/Sr. CTM and clinical operations in communication with clinical trial sites regarding study conduct, monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements
- Assists in tracking study specific payments and invoices
- Provides operational or work flow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed
- Collaborates on project teams, primarily with Research and Development, Regulatory, Safety, and Quality/Compliance
- Supports CTM/Sr. CTM and clinical operations members with administrative documents related to all clinical study programs, TMFs, and study start up activities
- Assists and supports CTM/Sr. CTM and clinical operations team in presentations of clinical information concerning specific projects
- Works on projects of moderate-to-high degree of difficulty in which analysis of situation or appropriate judgment and flexibility is required and should be exercised
Requirements:- Bachelor's degree in a health profession or science. Advanced degree a plus.
- At least 3 years of on-going clinical trials experience.
- Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.
- Knowledge of medical terminology.
- Ability to effectively work independently.
- Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook).
- Travel may be required (minimal).
This position may be available in the following location(s): US - Remote
For U.S. locations that require disclosure of compensation, the starting pay for this role is between $85,000.00 and $115,000.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.
U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
