Clinical Research Coordinator II

Flourish Research; Detroit (MI); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Tuition reimbursement

Parental leave

Employee referral program

Employee assistance program

Life insurance

Job summary

Flourish Research in Detroit, MI is seeking a Clinical Research Coordinator II to manage protocol visits, data documentation, and regulatory compliance. The role is onsite, with a Monday–Friday schedule during normal business hours, and requires strong clinical research experience, especially in oncology.

The coordinator will obtain informed consent, recruit subjects, and coordinate visits and training while maintaining HIPAA compliance and reporting adverse events as required.

Qualifications

• Two years of clinical research experience required or preferred.
• Oncology clinical research experience is desirable.
• Clinical skills such as vital signs, ECG/EKG, phlebotomy, and injections are highly preferred.
• Familiarity with e‑source reporting and electronic data capture platforms.
• Clear understanding of ICH, FDA, and GCP regulations.
• Strong organizational, attention to detail, and communication abilities.

Responsibilities

• Execute protocol-specified patient visits and procedures (phlebotomy, IVs, injections, vital signs, ECG/EKG).
• Document assessments and data per regulatory requirements and GCP; maintain source docs and CRFs/eCRFs.
• Obtain informed consent per IRB requirements and federal regulations.
• Recruit qualified subjects to meet enrollment timelines.
• Attend training, investigator meetings, and stay current with regulations and policies.
• Schedule and conduct visits per protocol timelines.
• Maintain HIPAA confidentiality and report adverse events promptly.
• Ensure availability of trial materials and communicate with study team as required.

Skills

Clinical research experience

Phlebotomy

ECG/EKG

Injections

e-source reporting

GCP/ICH regulations

Organizational skills

Communication skills

Microsoft Office

Education

Bachelor’s degree preferred

Job description

Position Overview

Flourish Research, a leader in clinical trial research, is hiring a Clinical Research Coordinator II for our Detroit, MI site. The position will work Monday‑Friday during normal business hours and is located onsite.

Responsibilities

• Execute protocol‑specified patient visits and procedures including phlebotomy, IVs, injections, vital signs, ECG/EKG, and other study‑specific tasks.
• Document assessments and study data according to regulatory requirements and GCP, maintain complete source documentation, and accurately complete CRFs/eCRFs.
• Obtain informed consent in compliance with federal regulations, GCP, and IRB requirements.
• Recruit qualified subjects ethically to meet enrollment timelines.
• Complete required and ongoing training, attend investigator meetings and courses, and stay current with changing regulations and company policies.
• Schedule and conduct visits according to protocol timelines.
• Protect confidentiality in accordance with HIPAA and all confidentiality agreements.
• Report adverse events promptly; report serious adverse events to the sponsor within 24 hours and notify the principal investigator, sub‑investigator, or supervisor.
• Ensure availability of trial materials such as study drug, laboratory supplies, CRFs, and other study resources.
• Maintain and document communication with leads, managers, principal investigators/sub‑investigators, and the study team per protocol and policy.
• Perform duties safely and efficiently, complying with all company policies and regulations.
• Represent Flourish Research professionally in all interactions.
• Carry out additional duties assigned by management.

Qualifications

• Bachelor’s degree preferred, but not required.
• Minimum of two years of clinical research experience.
• Experience in oncology clinical research.
• Clinical skills highly preferred: vital signs, ECG/EKG, phlebotomy, and injections.
• Familiarity with e‑source reporting via an electronic platform.
• Clear understanding of ICH, FDA, and GCP regulations.
• Impeccable organizational skills and meticulous attention to detail.
• Excellent communication and interpersonal skills to interact with principal investigators, study sponsors/CROs, potential subjects, and referral sources.
• Strong ethical compass with honesty, detail‑orientation, and self‑drive.
• High‑level critical thinking skills.
• Working knowledge of medical terminology and laboratory collection/processing/storage procedures.
• Proficiency with computers and Microsoft Office Suite.

Benefits

• Health, dental, and vision insurance plans.
• 401(k) with 100% employer match on the first 4% of employee contributions.
• Tuition reimbursement.
• Parental leave.
• Employee referral program.
• Employee assistance program.
• Life insurance and disability insurance.
• Generous PTO covering vacation, sick, personal days, and 8 paid holidays.

Equal Opportunity Employer

Flourish Research is an equal‑employment‑opportunity employer. Employment decisions are based on merit and business needs, and are not influenced by race, color, sex (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.