What You'll DoWe are seeking a
Study Start-Up Associate, level I or II dependent upon experience. This is a remote position.
You will serve as the primary point of contact to study sites during start-up, work in a team setting managing multiple clinical study protocols and will be responsible for all regulatory tasks pertaining to assigned studies. This role will be involved in studies from start-up through maintenance and closeout.
The primary responsibilities of this position include, but are not limited to, the following:
- Reviews Sample and Site Informed Consent forms for compliance with the rules and regulations set forth by the FDA.
- Reviewing and approving site activation packages
- Ensure that all assigned start up activities are on track and support study deliverables
- Maintaining accurate, complete and current information in the appropriate databases
- Organizes regulatory information and tracks study documents
- Collecting and reviewing, of regulatory documents for completeness and compliance to the rules and regulations set forth by the FDA and the study sponsor.
- Filing in eTMF system and accurate Trial Master File Maintenance
- Maintains Consistent site follow-up and ensure documents required are collected in a timely manner
- Ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
- Researches regulatory issues and provides guidance and advice to colleagues
- Participates in various start-up and Sponsor Kick-Off meetings
- Escalate study issues appropriately and in a timely manner
- Performs other duties as assigned
What You NeedLevel of Education:- Bachelor's degree required preferably in a life science field or equivalent
Prior Experience:- 1-4 years prior work experience required
- Oncology clinical trials experience required
- Randomized (larger trials) experience required
- Prior experience in a CRO/pharmaceutical environment preferred
- Prior Informed consent and Regulatory document review experience required
Additional Requirements:- Proficient knowledge of Word and Excel
- Detail oriented
- Knowledge of eTMF preferred
- Excellent verbal and written communication skills
- Fluent knowledge of written and verbal English
Skills and Competencies needed:- Self-motivated, leverage resources to complete work efficiently, using time effectively
- Takes a systematic approach to problem solving
- Highly organized ability to prioritize tasks and track assignments to meet the needs of internal and external customers
- Demonstrate openness and honesty while acting in accordance with moral, ethical, professional guidelines
- The ability to convey or share ideas in concise terms that others understand
- Correctly interprets messages, asks questions when clarification is needed
- Is adaptable and flexible to changes with a positive attitude and a willingness to learn new ways to accomplish work activities and objectives
- Ability to adjust and reprioritize with the needs of Theradex Oncology
- Works with others to establish and maintain a positive working relationship while offering added value and insight.
- Working collaboratively with others to agree on outcomes and actions to complete tasks or achieve goals
- Demonstrated persistence in bringing issues to closure
- Views situations from multiple perspectives and potential impact outside one's area
- Uses appropriate interpersonal style to gain acceptance of ideas and plans
What We OfferAt Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $60,000-$105,000 with bonus potential. We will assess the specific title and level of entry during the interview and assessment process since the actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for company provided sponsorship or relocation.
