Swat Coordinator

Care Access Research; United States; Remote; USD 60,000 - 90,000; Full time

Job summary

Care Access Research is seeking a skilled SWAT Team Coordinator responsible for supporting various clinical research sites. The role requires collaboration across teams, oversight of study protocols, and prior experience as a Clinical Research Coordinator. This opportunity combines clinical oversight with rapid deployment to enhance research site effectiveness and patient care.

Benefits

Diversity & Inclusion initiatives

Opportunity for travel

Collaborative team environment

Mentorship and training

Qualifications

• 1+ years experience as a Clinical Research Coordinator.
• Knowledge of medical and research terminology.
• Strong organization and communication skills.

Responsibilities

• Coordinate clinical trials and manage site activities.
• Prescreen candidates and schedule appointments.
• Maintain compliance with FDA regulations and ICH guidelines.

Skills

Communication Skills

Critical thinking

Team Collaboration

Organization

Education

BA/BS or equivalent experience

Tools

Clinical trials database

IVR systems

Electronic data capture

MS Word

MS Excel

Job description

Req#: b6f92b69-c224-40d8-aeca-b849ec206375

What We Do Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers.

Who We Are We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

We are SO glad you are reading this! But, before we go any further in this conversation, we have deal-breakers. You must meet all of the following criteria before applying:

You MUST have a minimum of 1 years of experience as a Clinical Research Coordinator .

Experience with EMR, medical terminology, ability to read/understand a protocol. A minimum of 1 year prior Clinical Research Coordinator experience

You must have the authorization to work in the US for any employer.

You must not need visa sponsorship, either now or in the future.

We are glad you are still reading.

Care Access is seeking a dedicated, experienced, and innovation-driven SWAT Team Coordinator. The SWAT Team Coordinators primary responsibility is working cross functionally to support the current Care Access Integrated Research Organization’s Site Network sites. The SWAT Team Coordinator is a versatile team member who is knowledgeable in clinical research practices within the Care Access Integrated Research Organization (IRO) Site Network. The Swat Team Coordinator can be deployed to any current Care Access IRO site to provide short-term/temporary support as a Clinical Research Coordinator, Chart Abstractor or other role that may be required per protocol (i.e., unblinded staff, operator, etc.). The Swat Team Coordinator will also serve as a Chart Abstractor for potential Care Access Sites and perform EMR reviews as assigned by the Senior Manager. The Swat Team Coordinator will also support the Site Development Manager with Site Evaluation visits for potential new IRO sites and Site Builds for newly selected sites.

On a day-to-day basis you will:

C linical Research Coordinator duties (performed under guidance of the Regional Manager):

Study Preparation:

● Ability to understand and follow institutional SOPs

● Review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc.

● Assist PI, Training Department, and the Trial Activation Manager to ensure that all training and study requirements are met prior to trial conduct

● Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff

● Assist with planning and creation of appropriate recruitment materials

● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database

● Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies

● Attend Investigator meetings as required.

● Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives

● Assist in the creation or review of sponsor provided protocol specific source documents

● Determine facility, equipment and outsource vendor requirements and availability

● Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)

● Ensure training of Assistant CRCs, CRC Is, site staff and/or sub-investigators is completed for required tasks

Study Management:

● Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines

● Maintain organized file for blank source documents, patient charts, CRFs and supplies

● Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records

● Collect and evaluate concomitant medication

● Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings

● Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave

● Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials

● Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access Research team in an ongoing fashion

● Maintain effective relationships with study participants and other care Access Research personnel

● Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management

● Communicate clearly verbally and in writing

● Accept accountability for actions and function independently

Patient Coordination:

● Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment

● Obtain informed consent per Care Access Research SOP and document process when revised ICF discussed with patient during course of the trial

● Administer delegated study questionnaires

● Collect and evaluate medical records

● Complete visit procedures and ensure proper specimen collection, processing, and shipment in accordance with protocol

● Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc.

● Review laboratory results, ECGs, and other test results (e.g. MRIs) for completeness and alert values, ensuring investigator review in a timely fashion

● Recognize and document adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator, Sponsor, and regulatory coordinator.

● Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol

● Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround

● Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance

● Monitor patient progress on study medication

Documentation:

● Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP

● Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion

● Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart

● Accurately transcribe data to CRF. Resolve data management queries and correct source data as needed

● Record protocol exemptions and deviations as appropriate with sponsor. Complete Memo-to-File for patient chart and regulatory filing if necessary

● Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing

● Maintain copies of patient-specific correspondence in source charts

● Assist regulatory personnel with completion of continuing/final review reports

EMR Review duties:

● Review and assess protocol to determine patient profile for EMR database review

● Develop screening funnels based on sponsor provided data; adjust based on real world data

● Using developed templates, create spreadsheets to help aid in review of database

● Either remotely or at the clinic, review database and gather requested information

Site Development duties:

● Assists with Site Evaluation Visits (SEV)

○ Assists with gathering and verifying information prior to the SEV (Medical Licenses, CLIA waiver, Physician CV, etc.)

○ Attends the meeting with the office manager or designated contact and the potential PI

○ Takes pictures/videos and measurements of the clinic spaces and equipment that may be used for research

○ Assists with the completion of the Site Evaluation Visit form, uploads photos/videos

● Assists the Site Development Manager with New Site Builds

○ Assists with completing the equipment list to ensure the needed supplies and equipment will be ordered/delivered to the site on or prior to the scheduled site build

○ Assists with the site build request and scheduling process with internal teams and the site

○ Assist with inventory of all items sent to the site. If any ordered items have not been delivered, work with the Site Development Manager to ensure items can be sourced locally while on site

○ Assist with ensuring the site is set up completely and is fully operational for a CRC; pivoting as needed

○ Assist with completing the notes to CRC document to ensure all information is documented about the site

● Focus on high operational standards, driving operational excellence

● Assist with training and mentorship of new hires

● Ensure consistency and coordination across functions, aligning to timelines and leading the team to meet key milestones

● Represent a team culture of collaboration and teamwork

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

To be successful in this role, you will bring:

● Excellent working knowledge of medical and research terminology

● Excellent working knowledge of federal regulations, good clinical practices (GCP)

● Ability to communicate and work effectively with a diverse team of professionals

● Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors

● Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals

● Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments

● Critical thinker and problem solver

● Friendly, outgoing personality; maintain a positive attitude under pressure

● Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done

● Must have a client service mentality

● Ability to balance tasks with competing priorities

● High level of self-motivation, energy and possess a high degree of urgency

● Excellent professional writing and communication skills

● Ability to work independently in a fast-paced environment with minimal supervision

● Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel

TRAVEL:

Up to 100%

EDUCATION:

● BA/BS, equivalent experience may substitute.

EXPERIENCE:

● Experience with EMR, medical terminology, ability to read/understand a protocol

● A minimum of 1 year of relevant work experience in clinical research

● A minimum of 1 year prior Clinical Research Coordinator experience

Certification/License:

● Research Professional Certification- CCRP or CCRC preferred





Diversity & Inclusion

We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the physicians and caring for patients.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement

Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.

About the company

With the fastest-growing network of clinical trial sites, Care AccessResearch empowers patients, physicians, and sponsors to accelerate thefuture of medicine.

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