We are seeking a detail-oriented and compassionate Clinical Research Associate to join our cord blood collection program in Detroit, United States. In this role, you will play a vital part in supporting our clinical research initiatives by managing cord blood collection procedures, ensuring compliance with regulatory standards, and maintaining the highest levels of sample integrity. You will work collaboratively with healthcare providers, expectant parents, and research teams to facilitate the collection and processing of cord blood samples for clinical research purposes. Your dedication to excellence and empathetic approach will directly contribute to advancing medical research and improving patient outcomes.
- Perform cord blood collection procedures following established clinical research protocols and standard operating procedures with precision and professionalism
- Educate expectant parents about the cord blood collection program, addressing questions and concerns in a professional, compassionate, and supportive manner
- Maintain accurate and detailed documentation of all collection activities, sample information, and patient interactions in compliance with HIPAA regulations and organizational standards
- Ensure proper handling, labeling, and storage of cord blood samples according to laboratory safety standards and quality assurance requirements
- Coordinate with obstetric staff and healthcare providers to schedule and facilitate timely collection procedures in a flexible and responsive manner
- Monitor and maintain inventory of collection supplies and equipment, reporting any deficiencies or maintenance needs promptly
- Collect and verify patient demographic and medical history information for research documentation purposes with meticulous attention to detail
- Assist with data entry and management using electronic health records and clinical research databases, ensuring accuracy and completeness
- Adhere to all regulatory requirements, including FDA and CLIA guidelines, maintaining current knowledge of compliance standards and best practices
- Participate in quality control activities and process improvements to enhance program efficiency, sample quality, and overall organizational goals
- Support recruitment and enrollment efforts for the cord blood collection program through professional and inclusive outreach
- Demonstrate problem-solving and critical thinking skills to address challenges and contribute to innovative solutions within the program
**Required Qualifications:**
- Demonstrated experience with phlebotomy, venipuncture, or blood collection procedures
- Knowledge of cord blood collection techniques and maternal-fetal specimen handling
- Understanding of clinical research protocols, regulatory compliance, and ethical standards
- Strong communication and interpersonal skills with ability to interact professionally with patients and healthcare team members
- Proficiency with electronic health records (EHR) systems and data management software
- Solid grasp of medical terminology and anatomy relevant to obstetric and hematology fields
- Excellent organizational and time management skills with ability to manage multiple tasks simultaneously
- Attention to detail and commitment to maintaining accurate documentation and sample integrity
- Knowledge of HIPAA regulations and patient confidentiality requirements
- Familiarity with laboratory safety protocols and infection control procedures
- Ability to work effectively in fast-paced healthcare environments
- Patient education and counseling skills with empathetic and supportive approach
**Preferred Qualifications:**
- Certification in phlebotomy or clinical laboratory science
- Prior experience in clinical research settings or cord blood banking programs
- Experience working in obstetric or maternal health environments
- Knowledge of FDA and CLIA regulatory requirements
- Bilingual capabilities (English and Spanish)
- Experience with quality assurance and continuous improvement initiatives
Contingent Role- Up to 20 hours per week depending on need
Able to work Tuesday, Wednesday or Thursday
Hours During the Week: 8:15 AM until 6:30 PM. In addition, every other Saturday for 3 hours, beginning at 10:00 AM or 11:00 AM.
