Clinical Research Assistant

Job Description

Job Description

Clinical Research Assistant

Position Overview

Diabetes & Endocrine Treatment Specialists (DETS) is seeking a motivated, dependable, and detail-oriented Clinical Research Assistant to join our research team. This position supports the daily conduct of clinical trials involving investigational medications and medical devices related to diabetes, endocrinology, obesity, and metabolic health.

The Clinical Research Assistant will work closely with investigators, research coordinators, and other clinical staff to assist with participant screening, study visits, clinical procedures, data collection, and research documentation.

We are looking for someone with prior clinical research experience who can contribute to daily research activities with minimal supervision once trained on our site procedures. The ideal candidate is organized, proactive, comfortable working directly with patients, and able to manage multiple responsibilities while maintaining accurate documentation and following study protocols.

Our workload is generally steady, with some days busier than others depending on scheduled study visits and research activities.

About Us

Diabetes & Endocrine Treatment Specialists (DETS) is a specialty clinic focused on diabetes, endocrinology, weight management, and clinical research. Our team is dedicated to improving patient care and helping bring new treatment options to patients through clinical research.

Our motto is: We focus on wellness, not illness.

Education

• High school diploma or GED required.
• Associate's or bachelor's degree in healthcare, biology, science, or a related field preferred.

Experience and Qualifications

• Minimum of 6 months of clinical research experience required.
• Previous experience in a clinical, healthcare, laboratory, or patient care setting preferred.
• Experience performing vital signs, ECGs, phlebotomy, specimen collection, processing, and shipping preferred.
• Familiarity with clinical research documentation, source records, Electronic Data Capture (EDC) systems, and sponsor query resolution preferred.
• Basic understanding of Good Clinical Practice (GCP), ICH guidelines, and clinical research protocols.
• BLS or Phlebotomy certification preferred.
• Previous experience as a Medical Assistant, CNA, CMA, EMT, Phlebotomy Technician, Laboratory Technician, or similar clinical role is a plus.
• Knowledge or experience in diabetes, endocrinology, or metabolic health preferred.

Essential Responsibilities

Clinical Research and Participant Support

• Assist investigators and research coordinators with the daily execution of clinical trials in accordance with study protocols, GCP, and applicable regulatory requirements.
• Assist with participant recruitment, prescreening, screening, enrollment, scheduling, and follow-up activities.
• Review patient medical records and EMR/EHR information to identify potential study candidates based on protocol inclusion and exclusion criteria.
• Serve as a point of contact for research participants during study visits, helping ensure a positive experience and addressing questions within the scope of the role.
• Assist with the informed consent process as delegated and appropriately trained.
• Coordinate study visits, appointment reminders, laboratory procedures, and other protocol-required activities.

Clinical Procedures and Data Collection

• Perform protocol-required clinical procedures as trained and delegated, including vital signs, height, weight, BMI, blood pressure, pulse oximetry, and ECGs.
• Assist with phlebotomy, specimen collection, processing, labeling, storage, and shipping according to protocol and laboratory requirements.
• Collect and document medical histories, adverse events, concomitant medications, and other study-related information.
• Assist with investigational medication and medical device procedures, including participant preparation, education, and documentation as directed by qualified study staff.
• Observe participants during study visits and promptly communicate safety concerns, abnormal findings, or changes in participant condition to the appropriate clinical staff.
• Ensure assigned study procedures are completed accurately and within protocol-required timelines.

Research Documentation and Data Management

• Accurately document study procedures, participant assessments, and clinical data in source documents and applicable research systems.
• Enter, review, and maintain participant data in Electronic Data Capture (EDC) systems.
• Assist with identifying and resolving sponsor data queries in a timely manner.
• Review study documentation for completeness, accuracy, and consistency.
• Assist with maintaining organized regulatory documents, participant records, and study files.
• Identify and promptly communicate potential protocol deviations, missing documentation, or data discrepancies to the research team.
• Maintain participant confidentiality and comply with HIPAA, GCP, and applicable regulatory requirements.

Research Operations and Team Support

• Assist with study start-up activities, visit preparation, and organization of research materials.
• Prepare examination rooms, research supplies, laboratory kits, and equipment for scheduled study visits.
• Monitor research supplies and assist with inventory management and equipment maintenance as needed.
• Communicate professionally with investigators, sponsors, study monitors, participants, and clinic staff.
• Assist with monitoring visits, audits, and other research-related activities as needed.
• Participate in required study training, staff meetings, and continuing education.
• Support other research and clinic activities as needed to help maintain efficient daily operations.

Skills and Abilities

• Strong attention to detail and commitment to accurate documentation and data collection.
• Good organizational and time-management skills with the ability to manage competing priorities.
• Strong critical thinking and problem-solving abilities.
• Self-motivated and proactive, with the ability to recognize tasks that need to be completed and take initiative.
• Ability to work independently with minimal supervision after appropriate training.
• Strong interpersonal and communication skills when interacting with patients, investigators, and research staff.
• Ability to work collaboratively and contribute to a team-oriented environment.
• Ability to follow detailed study protocols, written procedures, and regulatory requirements.
• Comfortable adapting to changing study schedules, priorities, and research needs.
• Willingness to assist with responsibilities outside regularly assigned tasks when needed to support the team.

Technical Competencies

• Proficiency with Microsoft Office, including Outlook, Word, Excel, PowerPoint, and SharePoint.
• Familiarity with electronic medical records (EMR/EHR), EDC systems, and clinical research documentation preferred.
• Ability to learn and navigate sponsor portals, research software, and electronic study systems.
• Basic knowledge of medical terminology and common clinical procedures.

Ideal Candidate

This position is well suited for someone who already has some clinical research or healthcare experience and wants to continue developing their skills in a specialty clinic setting.

Individuals pursuing careers in medicine, physician assistant studies, nursing, clinical research, or other healthcare fields are encouraged to apply if they meet the required qualifications.

We value individuals who are dependable, willing to learn, take ownership of their responsibilities, and recognize the importance of teamwork. There may be opportunities for increased responsibility and advancement within the research department for strong performers.

Schedule and Work Location

• Job Type: Full-time
• Schedule: Monday through Friday, day shift
• Clinic Hours: 8:00 AM to 5:00 PM
• No weekends
• An optional four-day, 10-hour schedule may be considered based on experience and clinic needs.
• Work Location: In person

Benefits

• Health insurance
• Dental insurance
• Vision insurance