Clinical Research Coordinator
To Apply for this Job Click Here Position:
Clinical Research Coordinator Primary Role:
The individual will work directly with the study team, IU IRB, sponsors, and study participants.
Studies may include drug trials and clinical research registries.
Primary Duties and
Responsibilities:
Collaborate with the clinical research manager, study team, and sponsors for study start-up and management.
Design recruitment strategies.
Monitor enrollment goals and modify recruitment strategies as needed.
Be prepared to address issues and offer solutions.
Perform subject interviews and assessments for data required by protocol.
Determine subject eligibility through screening process.
Educate subject on disease, explain study and study protocol, review and obtain informed consent.
Conduct and/or coordinate study procedures/interventions.
Correctly use or create source documents for data collection.
Enter study data per protocol within timeframe required by study.
Resolve study queries within a timely fashion.
Serve as an advocate for the subjects and their family.
Facilitate study drug supply orders, dispensation, and documentation.
Order and receive study laboratory kits.
Prepare kits for study use.
Communicate with laboratory, Principal Investigator, sponsor, and subjects regarding laboratory findings.
Maintain a high level of expertise through familiarity of clinical research literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
Prepare and maintain regulatory and subject binders.
Maintain current knowledge of regulatory affairs and/or issues.
Develop and maintain IRB protocol and standard operating procedures to ensure compliance with internal and external regulatory agencies.
Record and document protocol deviations.
Communicate with PI and sub-investigators about changes in studies.
Audit documents and pertinent files and prepare for storage.
Archive documents for study per sponsor/government/institutional requirements.
Ensure study compliance.
Capture and record adverse events data.
Maintain follow-up to determine resolution of adverse events.
Compose adverse event reports for oversight agencies.
Compose and submit IRB continuing review/amendments/close out information.
Schedule and prepare for monitoring visits.
Prepare and respond to Sponsor, FDA, or internal audits.
Qualifications:
Minimum Education:
Bachelor's degree in Science or health-related field plus at least two years' experience in clinical research; or Associate's degree in Allied Health professions/bachelor's degree in other disciplines plus three years' experience in clinical research required.
Clinical Research Certification (ARCP or SOCRA) also required.
Required knowledge, skills, and abilities:
This position requires excellent oral and written communication skills, organizational skills, and the ability to develop and maintain rapport with professionals and study participants.
It requires knowledge and understanding of case report forms/assessments, research methods, and study protocol.
Ability to work as a team player, maintains accurate and organized records, and work with some level of independence.
Strong interpersonal skills and extensive judgment are required to appropriately respond to participants' well-being, demeanor, and abilities.
Proficient use of computers, strong attention to detail, and the ability to multi-task are also necessary in this position.
Level of Decision Making:
Employee must be familiar with Institutional Review Board practices and other research guidelines.
Employee will be responsible for following Good Clinical Practice guidelines to conduct clinical research and train and direct research staff, where applicable, to do the same.
1341421_1689883062 To Apply for this Job Click Here Recommended Skills Assessments Attention To Detail Auditing Case Report Forms Clinical Research Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Clinical Research Coordinator Primary Role:
The individual will work directly with the study team, IU IRB, sponsors, and study participants.
Studies may include drug trials and clinical research registries.
Primary Duties and
Responsibilities:
Collaborate with the clinical research manager, study team, and sponsors for study start-up and management.
Design recruitment strategies.
Monitor enrollment goals and modify recruitment strategies as needed.
Be prepared to address issues and offer solutions.
Perform subject interviews and assessments for data required by protocol.
Determine subject eligibility through screening process.
Educate subject on disease, explain study and study protocol, review and obtain informed consent.
Conduct and/or coordinate study procedures/interventions.
Correctly use or create source documents for data collection.
Enter study data per protocol within timeframe required by study.
Resolve study queries within a timely fashion.
Serve as an advocate for the subjects and their family.
Facilitate study drug supply orders, dispensation, and documentation.
Order and receive study laboratory kits.
Prepare kits for study use.
Communicate with laboratory, Principal Investigator, sponsor, and subjects regarding laboratory findings.
Maintain a high level of expertise through familiarity of clinical research literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
Prepare and maintain regulatory and subject binders.
Maintain current knowledge of regulatory affairs and/or issues.
Develop and maintain IRB protocol and standard operating procedures to ensure compliance with internal and external regulatory agencies.
Record and document protocol deviations.
Communicate with PI and sub-investigators about changes in studies.
Audit documents and pertinent files and prepare for storage.
Archive documents for study per sponsor/government/institutional requirements.
Ensure study compliance.
Capture and record adverse events data.
Maintain follow-up to determine resolution of adverse events.
Compose adverse event reports for oversight agencies.
Compose and submit IRB continuing review/amendments/close out information.
Schedule and prepare for monitoring visits.
Prepare and respond to Sponsor, FDA, or internal audits.
Qualifications:
Minimum Education:
Bachelor's degree in Science or health-related field plus at least two years' experience in clinical research; or Associate's degree in Allied Health professions/bachelor's degree in other disciplines plus three years' experience in clinical research required.
Clinical Research Certification (ARCP or SOCRA) also required.
Required knowledge, skills, and abilities:
This position requires excellent oral and written communication skills, organizational skills, and the ability to develop and maintain rapport with professionals and study participants.
It requires knowledge and understanding of case report forms/assessments, research methods, and study protocol.
Ability to work as a team player, maintains accurate and organized records, and work with some level of independence.
Strong interpersonal skills and extensive judgment are required to appropriately respond to participants' well-being, demeanor, and abilities.
Proficient use of computers, strong attention to detail, and the ability to multi-task are also necessary in this position.
Level of Decision Making:
Employee must be familiar with Institutional Review Board practices and other research guidelines.
Employee will be responsible for following Good Clinical Practice guidelines to conduct clinical research and train and direct research staff, where applicable, to do the same.
1341421_1689883062 To Apply for this Job Click Here Recommended Skills Assessments Attention To Detail Auditing Case Report Forms Clinical Research Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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