What are the responsibilities and job description for the Clinical Research Coordinator position at Actalent?
Job Description
This is a PART TIME (20 HOURS PER WEEK) on site role.
A Research Coordinator is responsible for reviewing, processing,
and managing clinical research data and documents, both regulatory and patient
records. The CRC performs a variety of clinical procedures, and assists with
daily workload planning; ie; collect, record, report, and interpret data on
patients enrolled in and/or seeking enrollment in clinical studies according to
the protocol, SOPs and GCPs.
ESSENTIAL
DUTIES/RESPONSIBILITIES
- PART TIME HOURS
§ Provide clinical research support to investigators to prepare for
and execute assigned research studies, including:
o Collect, record, and maintain research subject study data
according to study protocols and SOPs, preserving quality control for content,
accuracy, and completeness.
o Collect and submit regulatory/ethics documentation as required by
the FDA and other regulatory bodies governing the conduct of clinical research.
o Recruit and screen participants for clinical trials and maintain
subject screening logs.
o Assist in the initial and ongoing consent process; orient research
subjects to the study, including the purpose of the study, procedures, and
research process.
o Maintain source documentation based on protocol requirements.
o Schedule and execute study visits and perform study procedures.
o Handle lab testing and analysis, including preparation of specimen
collection tubes, shipment, and lab logistics.
o Monitor subject safety and report adverse events/reactions to the
Principal Investigator and/or appropriate medical personnel.
o Correspond with research subjects and troubleshoot study-related
questions or issues.
o Participate in “huddles” to confirm daily study tasks are assigned
to team members and are executed to the expected standards.
§ Assist with study data quality checking and query resolution.
§ Perform a variety of complex clinical research procedures
including but not limited to ECG, sample collection, spirometry, vital signs,
dose verification, cannulation, and
cardiac telemetry monitoring,
if needed.
§ Assist investigator in verifying that research study objectives
are met on time, within budget and according to applicable protocol
requirements, clinical research regulations and quality standards.
§ Provide training to new investigator site staff members on
study-specific topics and requirements. Assist in maintaining adherence to
investigator site staff training requirements by auditing and maintaining
training records.
§ Prepare for and attend study monitoring visits, study audits, and
regulatory inspections with clinical research regulatory agencies.
§ Assist research site with coverage planning related to staffing
and scheduling for research studies.
§ Performs other duties and projects as assigned.
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 for other accommodation options.
Salary : $30 - $40