The Clinical Research Associate will report to the AVP, Clinical Operations and will be responsible for managing our clinical trials. The successful candidate will be a key interface with our contract research organizations (CROs), other vendors in support of our clinical trials, and clinical sites. In addition, the appropriate candidate will be responsible for all aspects of trial implementations and have oversight of clinical trial CROs and vendors. The successful candidate will work closely with the AVP, Clinical Operations and other Development/Rocket team members on clinical trial operations, timelines, and financials.
• Must meet all requirements for CRA position and have demonstrated proficiency in all relevant areas.
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• May resolve routine monitoring issues.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports for regulatory filings.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• May participate in abstract presentations, oral presentations and manuscript development at national/international conferences.
• Interface with team members in other functional areas to address routine study issues.
Education/Experience and Skills Requirements:
• At least 5+ years of experience and a RN, BSN, BS or BA in a relevant scientific discipline.
• Excellent verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.
• A successful candidate will have clinical experience with rare/Orphan disease products and/or gene therapy clinical trials.
Location: New York, NY / Cranbury, NJ
Travel Requirements: Travel is required within the USA and EU.
Relocation Assistance Available:
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Search Firm Representatives Please Read Carefully
Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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Resumes with cover letters may be submitted to firstname.lastname@example.org