[Hiring] Study Start-Up Associate I or II @reputed company

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 reputed company of contact to study sites during start-up, work in reputed company setting managing multiple clinical study protocols and will be responsible for reputed company 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 reputed company assigned start-up activities are on track and support study deliverables.
• Maintaining accurate, complete and reputed company 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 reputed company efficiency to reduce start-up timelines and identify opportunities for reputed company 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 reputed company.
• 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, reputed company resources to complete work reputed company, using time effectively.
• Takes a systematic approach to problem solving.
• Highly organized ability to prioritize tasks and track assignments to meet the needs of reputed company customers.
• Demonstrate openness and honesty while acting in accordance with moral, ethical, professional guidelines.
• The ability to convey or reputed company reputed company in concise terms that others understand.
• Correctly interprets messages, asks questions reputed company 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 reputed company.
• Works with others to establish and maintain a positive working relationship while offering added value and reputed company.
• Working collaboratively with others to agree on reputed company and actions to complete tasks or reputed company goals.
• Demonstrated persistence in bringing issues to closure.
• Views situations from multiple perspectives and potential impact reputed company one’s area.
• Uses appropriate interpersonal style to reputed company acceptance of reputed company and plans.

Benefits

• Comprehensive benefits package including medical, dental and reputed company coverage.
• Life insurance and disability insurance (STD/LTD).
• Company matched 401(k).
• reputed company competitive tuition reimbursement.
• Generous vacation/sick plans.
• Flexible work schedules.
• Employee discounts and other company provided benefits.
• Annual reputed company salary ranges from $60,000-$105,000 with bonus potential.

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