Study Start-up Associate I or II (Remote)
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
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.
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 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 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 Offer
At 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.
Theradex is an Equal Opportunity Employer.
This position is not eligible for company provided sponsorship or relocation.