Clinical Research Coordinator

Accel Research Sites; Farmington Hills (MI); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401k plan with safe harbor match

Health savings accounts

Job summary

Alcanza is seeking a Clinical Research Coordinator to join our Operations team at Quest Research Institute in Farmington Hills, MI. The CRC will ensure study execution in compliance with GCP, ICH, HIPAA, FDA regulations and SOPs.

Responsibilities include patient screening, consent, follow-up visits, data entry, vital signs/ECGs, sample handling, and coordination of study activities. Strong clinical procedures experience and bilingual ability are a plus.

Qualifications

• Medical Assistant diploma, LPN/LVN, EMT credential or Associate’s degree with 1 year clinical research/clinical experience.
• Proficiency performing basic clinical procedures (BP, vitals, EKGs, phlebotomy).
• Bi-lingual English/Spanish is a plus.
• Proficient with Microsoft Office, EHRs and 40+ wpm typing.
• Strong organizational and communication skills.

Responsibilities

• Screen patients for study enrollment.
• Obtain patient consents and schedule follow-up visits.
• Document in source clinic charts; enter data in EDC and answer queries.
• Obtain vital signs and ECGs; perform basic lab procedures per protocol.
• Maintain logs and study-specific supplies; coordinate with team and sponsors.
• Ensure confidentiality and HIPAA compliance in all activities.
• Assist with recruitment and tracking as needed.

Skills

Clinical procedures

Microsoft Office

EHR systems

Communication skills

Bilingual English/Spanish

Organization

Education

Medical Assistant diploma/LPN/LVN/EMT credential OR Associate degree

1 year clinical research/clinical experience

Job description

Clinical Research Coordinator

Department: Operations

Employment Type: Full Time

Location: Quest Research Institute - Farmington Hills, MI

Reporting To: Heather Fasczewski

Description

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, VA, SC, TN, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow.

The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.

Key Responsibilities

Essential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to:

• Screening of patients for study enrollment;
• Patient consents;
• Patient follow-up visits;
• Documenting in source clinic charts;
• Entering data in EDC and answers queries;
• Obtaining vital signs and ECGs;
• May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up;
• Requesting and tracking medical record requests;
• Updating and maintaining logs, chart filings;
• Maintaining & ordering study specific supplies;]
• Scheduling subjects for study visits and conducts appointment reminders;
• Building/updating source as needed;
• Conducting monitoring visits and resolves issues as needed in a timely manner;
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner;
• Filing SAE/Deviation reports to Sponsor and IRB as needed;
• Documenting and reporting adverse events;
• Reporting non-compliance to appropriate staff in timely manner;
• Maintaining positive and effective communication with clients and team members;
• Always practicing ALCOAC principles with all documentation;
• May assist with study recruitment, patient enrollment, and tracking as needed;
• Maintaining confidentiality of patients, customers and company information, and;
• Performing all other duties as requested or assigned.
• Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.;
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed;
• May set up, train and maintain all technology needed for studies.

Skills, Knowledge and Expertise

Minimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate’s degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus.

Required Skills:

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
• Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc
• Strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

Benefits

• Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire.
• Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.