Study Start-up Associate at Theradex Systems, Inc. in Princeton, New Jersey

Job Description:

Theradex Systems, Inc.


Theradex is an Equal Opportunity Employer.

US-NJ-Princeton | US
ID 2024-1348
Category Regulatory
Type Full Time

Who We Are

Celebrating 40+ Years!

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

What You'll Do

Study Start-Up Associate - Remote

We are seeking a Study Start-Up Associate, level dependent upon experience.

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
• 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 Need

Level 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 preferred
• Proficient knowledge of Word and Excel
• Detail oriented
• Excellent verbal and written communication skills
• Fluent knowledge of written and verbal English
• Knowledge or eTMF preferred

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

??Additional Requirements:?

• Proficient knowledge of Word and Excel
• Detail oriented
• Knowledge or eTMF preferred
• Self-motivated, leverage resources to complete work efficiently, using time effectively

• Excellent verbal and written communication skills

• Fluent knowledge of written and verbal English

What We Offer

We provide a supportive environment and through our expertise, innovative systems and processes and we give you the tools to be successful for ambitious and talented people that strive in a fast-paced entrepreneurial environment. We offer a competitive compensation and benefits package including medical, dental, vision, life insurance, short term/long term disability (STD/LTD), 401(k), tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.

This position does not offer company provided sponsorship or relocation assistance.

No agencies please.

PI258940348

Salary:

$1.00

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