Job Description

This is a PART TIME (20 HOURS PER WEEK) on site role. This is a flexible work schedule, but must be able to commit to working Monday through Friday 8am to 5pm EST. This is an ON SITE role located in Tampa, FL focusing on mental health clinical trials!

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.