Clinical Research Data and Regulatory Coordinator ***on-site***

Position Summary: Within the Department of Clinical Research, and under funding provided by sponsor organizations, the Clinical Research Data and Regulatory Coordinator performs all duties under the general supervision of the Director of Clinical Research and/or Senior Research Nurse(s)-who are Registered Nurses licensed in the State of New Jersey and the Senior Clinical Research Coordinator(s). The Coordinator works in collaboration with the Clinical Research Team and Principal Investigator, and Sub-Investigators while following established procedures and current protocol requirements.

The Clinical Research Data and Regulatory Coordinator prepares, completes and maintains all Institutional Review Board (IRB) regulatory submissions, including initial applications, continuing reviews, safety reports, and amendments, and other required submissions in support of clinical research. The Coordinator prepares submissions for reportable events and facilitate communication and correspondence between the Clinical Research Team and sponsoring agencies.

The position includes abstracting data; collecting protocol-specific information from physicians, nurses, patients, family members, local caregivers, and other authorized sources using protocol-specific methods; and obtaining informed consent from research participants in accordance with the approved protocol, IRB requirements, and applicable regulations. The Clinical Research Data and Regulatory Coordinator ensures that designated clinical research regulatory and data management activities at all clinical research sites are conducted in accordance with applicable laws, regulations, institutional policies, and protocol requirements. Additional duties may be assigned by the supervisor or described in the position description.

The Clinical Research Data and The Clinical Research Data and Regulatory Coordinator ensures compliance with established data collection, documentation, and reporting requirements for assigned clinical research protocols. This position responds to and resolves inquiries from collaborating research organizations and study sponsors and prepares data reports that demonstrate the potential impact of research activities on the organization.

The Clinical Research Data and Regulatory Coordinator works closely with the Clinical Research Director, Research Coordinator, research team, Principal Investigators, and Co-Investigators to establish clinical trial requirements, collect and extract necessary study information, monitor study progress, and support the successful completion of clinical trials.

Experience: Entry level will be considered with certification or commensurate research and/or cardiovascular experience

Required: 1-2 years of medical-related clinical experience

Preferred: Cardiovascular experience, data management, regulatory and/or research experience

Education : Applicable certification or commensurate cardiovascular experience will be considered in lieu of degree.

Required: Associates degree in a science-related field

Preferred: Bachelor's degree in a related field

License and Credentials:

Required: Certificate of successful completion "Human Research Protection Foundational Training" from US Department of Health and Human Services (HHS), and/or "Good Clinical Practice" (GCP) from National Drug Abuse Treatment Clinical Trials Network or Collaborative Institutional Training Initiative (CITI) within two weeks of hire

Preferred: Previous experience with clinical research data collection and regulatory submissions

Skills:

Required: Must be able to meet deadlines and prioritize workload and complete multi-step procedures on several studies simultaneously. Knowledge and experience with medical and scientific terminology and concepts. Effective communication and interpersonal skills effectively managing stressful situations. Demonstrated ability to prioritize and multitask to meet multiple deadlines. Fluency in English (oral and written), proficiency in MS Outlook, Word, Excel PowerPoint. Working knowledge of general scientific research. Ability to work productively independently and as part of a team.

Preferred: Compliance management; auditing, eTMF, iMedidata, and/or REDCap experience; multi-lingual

Supervision: Responsibilities of the position require no supervision or direction of others.

Hours: 80 hours per pay period

The minimum starting rate for this position is $20.07

When determining a team members base rate, several factors may be considered as applicable (e.g., years of recent relevant experience, education, credentials, and internal equity).

At Deborah, healthcare is still about caring...for patients and team members. That is why we offer an outstanding benefits package, which includes healthcare coverage for team members in regularly budgeted positions of at least 30 hours per week. The benefits package also includes generous paid time-off, 401K matching contribution, tuition assistance, short and long term disability benefits, life insurance, meal discount, dependent care subsidy, adoption assistance and free parking

Equal Opportunity Employer
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