Clinical Research Coordinator
Description:
- Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the Research Manager.
- The research coordinator is responsible for the overall successful implementation and ongoing site management of the research studies.
- Actively recruits and screens eligible patients for research protocols as assigned and Assisting with Informed Consent process.
- Coordinates and implements enrollment and follow-up procedures to collect, data from patient charts, medical records, questionnaires, and other sources. Cross-trains as backup on other studies as assigned. Completes worksheets and source document forms.
- Performs all study lab processing including centrifuging, aliquoting, storage, freezer maintenance and shipping as assigned.
- Assures that study-related laboratory tests and diagnostic procedures are completed, reviewed, and confirmed when necessary. Completes grading of labs per CTCAE V5.0 toxicity table and/or other study specific grading scales.
- Completes Case Report Forms/Source Templates and pertinent study-related forms accurately and within specified time limits. Resolves any CRF comments, errors, queries and delinquencies that come up with strict time-frames. Completes quality assurance assignments in preparation for Site Monitoring Visits.
- Communicates with providers, protocol teams, sponsors, as well as others from the research team regarding the clinical management of signs, symptoms, toxicities, abnormal labs, deviations, adverse events, etc.
- Maintains contact with study patients to facilitate study retention and their care, including communication regarding study requirements, coordinates drug dispensing, and other procedures, treatment, etc.
- Understands GCP, IATA and FDA requirements, ensuring compliance with regulatory agencies. Maintains patient charts as assigned.
- Maintains patient schedules as assigned.
- Attends pertinent educational or study activities and reviews current literature relevant to clinical trials assigned.
Skills:
Chart review, Pre-screening patients, Patient recruitment, oncology
Top Skills Details:
Chart review,Pre-screening patients,Patient recruitment,oncology
Additional Skills &
Qualifications:
Works independently with little supervision to coordinate and oversee the activities of the assigned protocols.
May assist with supervision of lower level staff members
A minimum of two-year oncology or clinical research experience;
Electronic Health Records experience.
Candidates must have strong written and oral communication skills,
Must have the ability to work well under the pressure of meeting mandatory deadlines.
Must have ability to plan, organize and coordinate multiple work assignments simultaneously, while maintaining proficiency and efficiency.
Need to have the ability to read, write, interpret and apply instructions to assigned activities.
Experience working with computers and MS Office software environment.
Valid Driver's License, in state of residency, for travel to clinics.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.Estimated Salary: $20 to $28 per hour based on qualifications.
- Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the Research Manager.
- The research coordinator is responsible for the overall successful implementation and ongoing site management of the research studies.
- Actively recruits and screens eligible patients for research protocols as assigned and Assisting with Informed Consent process.
- Coordinates and implements enrollment and follow-up procedures to collect, data from patient charts, medical records, questionnaires, and other sources. Cross-trains as backup on other studies as assigned. Completes worksheets and source document forms.
- Performs all study lab processing including centrifuging, aliquoting, storage, freezer maintenance and shipping as assigned.
- Assures that study-related laboratory tests and diagnostic procedures are completed, reviewed, and confirmed when necessary. Completes grading of labs per CTCAE V5.0 toxicity table and/or other study specific grading scales.
- Completes Case Report Forms/Source Templates and pertinent study-related forms accurately and within specified time limits. Resolves any CRF comments, errors, queries and delinquencies that come up with strict time-frames. Completes quality assurance assignments in preparation for Site Monitoring Visits.
- Communicates with providers, protocol teams, sponsors, as well as others from the research team regarding the clinical management of signs, symptoms, toxicities, abnormal labs, deviations, adverse events, etc.
- Maintains contact with study patients to facilitate study retention and their care, including communication regarding study requirements, coordinates drug dispensing, and other procedures, treatment, etc.
- Understands GCP, IATA and FDA requirements, ensuring compliance with regulatory agencies. Maintains patient charts as assigned.
- Maintains patient schedules as assigned.
- Attends pertinent educational or study activities and reviews current literature relevant to clinical trials assigned.
Skills:
Chart review, Pre-screening patients, Patient recruitment, oncology
Top Skills Details:
Chart review,Pre-screening patients,Patient recruitment,oncology
Additional Skills &
Qualifications:
Works independently with little supervision to coordinate and oversee the activities of the assigned protocols.
May assist with supervision of lower level staff members
A minimum of two-year oncology or clinical research experience;
Electronic Health Records experience.
Candidates must have strong written and oral communication skills,
Must have the ability to work well under the pressure of meeting mandatory deadlines.
Must have ability to plan, organize and coordinate multiple work assignments simultaneously, while maintaining proficiency and efficiency.
Need to have the ability to read, write, interpret and apply instructions to assigned activities.
Experience working with computers and MS Office software environment.
Valid Driver's License, in state of residency, for travel to clinics.
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.Estimated Salary: $20 to $28 per hour based on qualifications.
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