Job Details
Description
Position Definition :
The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate and analyze clinical data.
Essential Functions :
Works with PI, co-investigators and trainees on the research team to facilitate completion of research proposals, projects, manuscripts, abstracts and presentations.
This involves contributions to statistical analysis, curation of bioinformatics data, pathway analysis, data review and presentation, data visualization (figures, graphs), literature review, and other activities to advance research productivity.
Monitors study activities to ensure compliance with protocols and relevant local, federal, and state regulatory and institutional policies.
Maintains required records of study activity, including case report forms, drug dispensation records, or regulatory forms.
Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
Assesses eligibility of potential subjects through screening interviews, reviews of medical records, and discussions with physicians and nurses.
Oversees subject enrollment to ensure that informed consent is appropriately obtained and documented.
Records adverse event and side effect data and confers with investigators regarding reporting events to oversight agencies.
Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identifies protocol problems, informs investigators of trials, or assists in problem resolution efforts such as protocol revisions.
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Participates in the preparation and management of research budgets and monetary disbursements.
- Works with NCIRE Office of Sponsored Research to balance trial accounts and maintain the accuracy of available funding.
- Ensures proper paperwork is submitted to internal and external agencies for grant updates.
- Instructs research staff in scientific and procedural aspects of studies, including standards of care, informed consent procedures, or documentation procedures.
- Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
Communicates with laboratories or investigators regarding laboratory findings.
- Reviews scientific literature, participates in continuing education activities, and / or attends conferences and seminars to maintain knowledge of clinical studies affairs and issues.
- Orders drugs or devices necessary for study completion.
- Solicits industry-sponsored trials through contacts and professional organizations.
- Perform other duties as assigned.
Job Requirements :
Master of Public Health or Master of Science degree, or equivalent preferred; 1-3 years of relevant work experience or bachelor’s degree in a related field with 7-10 years of relevant work experience desirable.
Preferred candidates will have three or more years as a clinical research professional (certification as a CCRC is desired)
- Quantitative skills with proficiency in statistical analysis software packages, R (preferred), SAS, STATA, Python. Bioinformatics proficiency desirable.
- Understanding of the principles of administration and grant management.
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.
- Ability to work well independently as well as in a team environment.
- Good organizational and Microsoft Office skills.
- Ability to work with minimal supervision.
- Possess the ability to work well under pressure, multi-task, and manage deadlines.
The base salary range for this position is $66,.00 - $,.32 per year. The base salary actually offered to a successful candidate will take into account various relevant and non-discriminatory business factors including, without limitation, the candidate’s geographic location, job-related experience, knowledge, and skills, and education, as well as internal equity considerations.
A successful candidate may also be eligible to earn additional compensation including bonuses.
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