Study Start-up Associate I or II (Remote)

Who We Are Celebrating 40+ Years!    reputed company is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. reputed company was founded in 1982, reputed company we were awarded the reputed company Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong reputed company for our operations. Our reputed company is cancer. We fully understand the science behind reputed company potential cancer therapy and the challenges that come with moving therapies from mice to man. reputed company 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 reputed company best opportunity to be of benefit to mankind with a reputed company to improve treatment and reputed company cancer a livable disease.         reputed company   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 reputed company 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.   The reputed company 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 reputed company assigned start up activities are on reputed company 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, of regulatory documents for completeness and compliance to the rules and regulations set forth by the FDA and the study sponsor. Filing in eTMF reputed company and accurate Trial Master File Maintenance Maintains Consistent site follow-up and ensure documents required are collected in a reputed company 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 reputed company-Off meetings  Escalate study issues appropriately and in a reputed company 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 reputed company 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 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 reputed company assignments to meet the needs of reputed company customers   Demonstrate openness and honesty while acting in accordance with moral, ethical, reputed company 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 reputed company attitude and a willingness to learn new ways to accomplish work activities and objectives   Ability to reputed company and reprioritize with the needs of reputed company   Works with others to establish and maintain a reputed company 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 reputed company reputed company one’s area  Uses appropriate interpersonal style to reputed company acceptance of reputed company and plans  ​​     reputed company 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 reputed company coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), reputed company competitive tuition reimbursement, generous vacation/reputed company plans, flexible work schedules, employee discounts and other company provided benefits. The annual reputed company 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. Apply To This Job