Open Positions

Position Description:

The Clinical Trial Educator II is responsible for sourcing, educating, recruiting, and scheduling qualified candidates for clinical research protocols for the organization. This role combines remote work with field activities, allowing the CTE II to engage with potential candidates both virtually and in person.

Job Responsibilities:

• Conduct protocol reviews and build study profile criteria into the CTMS.
• Accurately collect reported medical histories and conmeds to determine if the patient meets pre-screening eligibility.
• Support the recruitment team with frequent communication on patient match numbers and discuss any challenges that could have a negative impact on our ability to enroll successfully.
• Must have exceptional organizational skills.
• Business casual attire is required for all fieldwork.
• Coordinate and schedule interviews, both in person and remotely, and facilitate the overall recruitment process.
• Stay up to date with protocol amendments, regulations, and best practices.
• Able to pivot tasks when necessary.
• Exceptional interpersonal sales and customer service skills.
• Excellent written and verbal communication skills.
• Advanced knowledge of medical terminology both written and verbal.
• Comfortable with using technology-based platforms.
• Self-Motivated and result driven.

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Pay Range: $19.00-23.00

Position Description:

We are looking for candidates with familiarity with medical/research backgrounds and excellent interpersonal skills for the position of Certified Medical Assistant (CMA). This role is proficient in adult and pediatric phlebotomy (blood draw) as well as with administration of vaccines. The role supports Clinical Research Coordinators (CRCs) in their daily activities of carrying out clinical trials under the oversight of the principal investigator. The CMA will be responsible for both clinical and administrative duties related to the conduct of clinical research at the site.

Job Responsibilities: Abide by local, state, GCP, ICH and FDA guidelines and regulations for the conduct of clinical trials. Overseeing the smooth running of clinical trials at site in collaboration with CRCs, study investigator(s) and other team members Complete all required organization and study specific training in a timely manner. Setting up rooms for patient visits, requesting medical records, follow-up phone calls to patients. Knowledge of performing vital signs, vaccine administration and phlebotomy. Process study labs per requirements. Monitoring research participants to ensure adherence to study participation and maintain compliance. Perform regular inventory checks and ensure the necessary supplies and equipment for a study are in stock and in working order. Engaging with research subjects and understanding their concerns.

Qualification Requirements:

Upwards of 2 years’ experience as a medical assistant or clinical research assistant.

Currently trained in phlebotomy, vaccine administration, performance of vital signs, medical history

collection, and administration of EKGs.

Attention to detail and has excellent organizational skill.

Exceptional interpersonal and customer service skills

Outstanding written and verbal communication

Willingness to continually self-educate.

 

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We are looking for candidates who have a clear understanding of clinical protocols and medical terminology to perform accurate medical record reviews and be able to build study profiles based on each protocol requirement. To also assist with providing timely updates to the company and or its affiliates to ensure the continued quality of patient matches. This candidate requires a mid-level understanding of IT systems and the ability to communicate and escalate findings to leadership in a timely manner.

Study Engagement Specialists Responsibilities:

• Conduct protocol reviews and build study criteria into the internal system to ensure we have the best possible patient matches.
• Collaborate with Aspen Insight to offer ideas and or suggestions to improve the quality of patient matches.
• Support the recruitment team with frequent communication on patient match numbers and discuss any challenges that could have a negative impact on our ability to enroll successfully.
• Support business development by providing timely outcomes on feasibility review and patient match numbers.
• Assist the Director of Patient Recruitment with the creation of study summaries.
• Able to pivot tasks when necessary.
• Exceptional interpersonal sales and customer service skills
• Excellent written and verbal communication skills
• Intermediate knowledge and comfort with medical terminology
• Comfortable with using technology-based platforms.
• Self-Motivated and result driven.

Compensation: Competitive base rate dependent on experience.

Job Type: Full-time

Salary: $18.00 – $22.00 per hour

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Experience level:

• 1 year

Schedule:

• Monday to Friday

Experience:

• Recruiting: 1 year (Preferred)

Work Location: Remote

 

 

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Position Description:

• Assist with Ad-hoc requests from clients, corporate team, leadership team, as well as clinical team as deemed necessary.
• Become the on-site SME of the Accounts Receivable process, as well as of the monthly billing.
• Each month create all necessary invoices related to revenue and/or pass throughs in CTMS (RealTime),
• Have a complete understanding of the invoicing requirements internally of Cedar Health Research, as well as externally of its clients.
• Learn the various client invoicing portals and platforms to facilitate more transparent and complete client invoicing process.
• Create and enhance current SOP of receivables and billing process.
• Fund site stipend accounts in our CTMS system.
• Be able to decipher all client payment remittance be it received directly or obtained via client portal.
• Continually seek ways to improve client billing, as well as the entire A/R process
• Review, analyze and negotiation of budgets with CRO/Sponsors to maximize profitability and optimize use of clinical staff resources.
• Review proposed budgets in conjunction with study protocol, startup and other site sponsor determined site requirements.
• Determine company costs associated with required study activities in collaboration with finance and clinical team leaders.
• Through knowledge of business model be able to independently propose counter offers in a timely manner to achieve desired financial margins.
• Respond to sponsor/CROs with initial counter offers and revisions in a timely basis.
• Prioritize and manage multiple budgets in workflow to meet study start up timing goals.
• Review and analyze proposed sponsor clinical trial agreements.
• Identify all contract terms that require modification based on corporate SOPs and legal guidelines.
• Collaborate with in house counsel on proposed language changes.
• Prioritize and manage multiple contracts in workflow to meet study start up timing goals.
• Track all activity in company CRM database, providing weekly reporting to management on status of all pending budgets and contracts.

Job Type: Full-time

Salary: $70,000.00 – $90,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Physical setting:

Office

Schedule:

Monday to Friday

Supplemental pay types:

Bonus pay

Ability to commute/relocate:

Dallas, TX 75251: Reliably commute or planning to relocate before starting work (Required)

Experience:

Accounting: 1 year (Preferred)
Microsoft Excel: 1 year (Preferred)

Work Location: One location

 

 

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Position Description: Experienced, organized, detail-oriented candidates with research and regulatory backgrounds and for the position of Regulatory Specialist. This role is responsible for the successful maintenance of regulatory documents, regulatory binders, CTMS of all clinical trials. Further, this role will help provide Quality Assurance and Quality Control to the Clinical Operations department and its processes. Assist in formulation and carrying out Standard Operation Procedures. In addition, the Regulatory Specialist should possess knowledge strong interpersonal and communication skills, and the ability to maintain confidentiality. Job Responsibilities: Abide by local, state, GCP, ICH and FDA guidelines and regulations for the maintenance of regulatory operations in clinical trials. Ensure all required regulatory packets (documents) and IRB submissions are completed in a timely manner. Assist to facilitate all required organization and study specific trainings are completed in timely manner by appropriate study staff. Participate in kick-off meetings for conduct of research studies to ensure all regulatory documents are in place. Review SOPs with lead of Clinical Operations to ensure SOPs are put in place to oversee current and future processes. Provide responsive and diligent collaboration with sponsor/CRO study teams, including prompt resolution of pending action items. Assist in performing regular quality checks in company drive and CTMS for all regulatory documents. Engage with staff and providers in a cordial and effective manner. Qualification Requirements: One (1) year of recent regulatory experience in a hospital, clinic, or similar health care setting. Regulatory experience with Central IRB(s) and preferrable with local IRB(s) too. At least one (1) year clinical trials research experience preferred Knowledge of regulatory terminology, clinical trials and GCP concepts Detail oriented and meticulous in all aspects of work Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative Must have professional demeanor, strong communication skills with the public as well as physicians and co-workers Ability to work well independently as well as in team environment Strong interpersonal, customer service and multi-tasking skills are critical Must be proficient in databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire Possess the ability to work well under pressure, multi-task, and manage deadlines Knowledge of GCP, federal, state, and local regulations, including HIPAA policies and procedures Additional Requirements: N/A Pluses: Fluency in Spanish

Job Type: Full-time

Salary: $20.00 – $27.00 per hour

Benefits:

401(k)

Dental insurance

Health insurance

Paid time off

Schedule:

Monday to Friday

Supplemental pay types:

Bonus pay

Ability to commute/relocate:

Dallas, TX 75251: Reliably commute or planning to relocate before starting work (Required)

Experience:

FDA regulations: 1 year (Preferred)

Work Location: Hybrid remote in Dallas, TX 75251

 

 

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Position Description:

Experienced candidates with familiarity to medical/research backgrounds and excellent interpersonal skills for the position of Clinical Research Assistant (CRA). This role supports Clinical Research Coordinators (CRCs) in their daily activities of carrying out clinical trials under the oversight of the principal investigator. The CRA will be responsible for both clinical and administrative duties related to the conduct of clinical research at the site.

Abide by local, state, GCP, ICH and FDA guidelines and regulations for the conduct of clinical trials. Overseeing the smooth running of clinical trials at site in collaboration with CRCs, study investigator(s) and other team members. Complete all required organization and study specific training in timely manner. Assisting with conduct of research study and GCP practices. Setting up rooms for patient visits, request medical records, follow-up phone calls to patients, etc. Collecting source obtained from research and transcribe into case report forms. Willingness to learn clinical procedures such as vital signs, EKG and phlebotomy. Process study labs per requirements. Monitoring research participants to ensure adherence to study participation and maintain compliance. Perform regular inventory checks and ensure the necessary supplies and equipment for a study are in stock and in working order. Engaging with subjects and understanding their concerns.Upwards of 2 years’ experience as a medical assistant or clinical research assistant. Currently trained or willing to be trained in phlebotomy, vaccine administration, performance of vital signs, medical history collection, and administration of EKGs. Attention to detail. Exceptional interpersonal and customer service skills. Outstanding written and verbal communication. Excellent organizational skill. Willingness to continually self-educate.

Salary: $20.00 – $24.00 per hour

Benefits:

401(k)

Dental insurance

Health insurance

Paid time off

Schedule:

Monday to Friday

 

 

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Job Description

Title: Clinical Research Coordinator

Location: Dallas, Texas Metro Area

Reports to: Clinical Operations Manager

Summary:

We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of Clinical Research Coordinator (CRC). This role is responsible for the successful conduct of clinical trials under the oversight of the principal investigator. The CRC will be responsible for both clinical and administrative duties related to the conduct of clinical research at the site.

Clinical Research Nurse Coordinator Responsibilities:

• Abide by local, state, GCP, ICH and FDA guidelines and regulations for the conduct of clinical trials.
• Overseeing the smooth running of clinical trials at site in collaboration with study investigator(s).
• Complete all required organization and study specific training in timely manner, including attendance at offsite investigator meetings
• Supervision and training of site research site staff, including study coordinators, research assistants and tab technicians
• Participate in the planning and conduct of research participant recruitment efforts
• Conduct the proper consenting of research participants
• Collecting source obtained from research and transcribe into case report forms.
• Perform medically qualified clinical procedures such as vital signs, EKG and phlebotomy
• Process study labs per requirements
• Provide clinical research training and mentoring to study team.
• Provide responsive and diligent collaboration with sponsor/CRO study teams, including prompt resolution of queries and other action items.
• Monitoring research participants to ensure adherence to study participation.
• Ensuring that the necessary supplies and equipment for a study are in stock and in working order.
• Engaging with subjects and understanding their concerns.

 

 

Clinical Research Coordinator Requirements:

• 3 years’ experience as a clinical research coordinator on phase II & III studies
• Currently trained or willing to be trained in phlebotomy, performance of vital signs, medical history collection, and administration of EKGs
• Attention to detail
• Exceptional interpersonal and customer service skills
• Outstanding written and verbal communication
• Excellent organizational skill
• Willingness to continually self-educate
• Pluses
  • Experience as a research coordinator in pediatrics and/or women’s health studies
  • Fluency in Spanish

Compensation: Dependent on medical/clinical qualifications and experience

 

 

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