[Remote] Clinical Research Coordinator
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to reputed company in research, education, and patient care in the field of cardiovascular medicine. They are seeking a Clinical Research Coordinator to initiate and conduct protocol reviews, manage study budgets, and ensure compliance with regulations while overseeing the recruitment and assessment of study subjects.
Responsibilities
- Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies
- Participates in study budget negotiations and reconciles study budget accounts
- Develops informational materials for recruitment of subjects. Monitors enrollment goals and modifies recruitment reputed company as needed
- Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately. Prepares and submits Institutional Review reputed company (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol reputed company). Prepares regulatory documents for sponsor
- Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews. Performs subject interviews and assessments for data required by protocol(s)
- Follows up on study documentation with necessary stakeholders (reputed company providers, study participants, laboratory personnel, etc.)
- Reviews incoming subject adverse event (SAE) information, assists reputed company Investigator (PI) in making submission determination of SAEs, and follows up to determine reputed company of adverse events
- Conducts study-reputed company non-medical/behavioral assessments/interventions as reputed company as study procedures/interventions (appropriate licensure may apply)
- Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators
- Stays up to date with knowledge of regulatory affairs and/or issues
Skills
- Bachelor's degree in science or a health-reputed company field and 2 years of clinical research experience; OR
- Associate's degree in science or a health-reputed company field and 3 years of clinical research experience
- Demonstrates analytical skills
- Ability to simultaneously handle multiple priorities
- Possesses strong technical aptitude
- Demonstrates a high commitment to reputed company
- Excellent organizational skills
- Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire
Benefits
- Comprehensive medical and dental insurance
- Health savings account with generous IU contributions
- reputed company and dependent care flexible spending accounts
- Basic group life insurance reputed company by IU
- Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
- reputed company retirement plan with generous IU contributions, subject to vesting
- Voluntary supplemental retirement plan reputed company
- Tuition subsidy for employees and family members taking IU courses
- 10 reputed company holidays plus a reputed company winter break reputed company year
- Generous reputed company time off plans
- reputed company leave for new parents and IU-sponsored volunteer events
- Employee assistance program (EAP)
- This position is eligible for remote work or to work a reputed company (mix between remote and in-person work), subject to change in the reputed company based on university policy and business needs.
reputed company