Study Start-up Associate I or II (Remote)

Theradex Oncology•Princeton, NJ

6d•$60,000 - $105,000•Remote

About The Position

Theradex Oncology is a full-service CRO with over 40 years of experience, specializing in early and late-phase oncology trials globally. Founded in 1982, our strong association with the National Cancer Institute (NCI) underpins our operations. Our mission is to ensure that new discoveries in cancer drug development have the best opportunity to benefit mankind, with a vision to improve treatment and make cancer a livable disease. We are seeking a Study Start-Up Associate, level I or II depending on experience, for a remote position. This role serves as the primary point of contact for study sites during the start-up phase, working in a team to manage multiple clinical study protocols and handle all regulatory tasks. The position is involved in studies from start-up through maintenance and closeout.

Requirements

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 Informed consent and Regulatory document review experience required.
Proficient knowledge of Word and Excel.
Detail oriented.
Excellent verbal and written communication skills.
Fluent knowledge of written and verbal English.
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.
Works 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.

Nice To Haves

Prior experience in a CRO/pharmaceutical environment preferred.
Knowledge of eTMF preferred.

Responsibilities

Reviews Sample and Site Informed Consent forms for compliance with FDA rules and regulations.
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 with FDA rules and regulations and study sponsor requirements.
Filing in eTMF system and accurate Trial Master File Maintenance.
Maintains consistent site follow-up and ensures required documents 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.