Role Description We 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.

• 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 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 ensures 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.

Qualifications

• Bachelor’s degree required, preferably in a life science field or equivalent.
• 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.

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.

Benefits

• Comprehensive benefits package including medical, dental and vision coverage.
• Life insurance and 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.
• Annual base salary ranges from $60,000-$105,000 with bonus potential.