Clinical Research Associate I Prdm Jobs

Conduct all types of visits including, qualification, initiaiton, monitoring and close out

Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

Ensure good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements

Minimum 1.5 years monitoring experience

Strong verbal and written communication skills

8-12 days on site per month

Ability to multi-task and have good organizational and time management skills.

Experience in clinical research or the medical field preferred

Experience with Electronic Data Capture (EDC) systems, for the purpose of clinical research, preferred.

Experience with programming and coding (e.g., HTML and Java) required.

Possess excellent written and oral communication skills.

Critical thinking and problem-solving skills

Basic knowledge of analytical chemistry methods Sincere interest in translating basic research insights into impactful therapeutics

Operate and maintain robotic systems for high-throughput assays.

Conduct physicochemical property assays, including but not limited to logD, pKa, and stability tests.

Collect, analyze, and interpret data generated from assays, ensuring high-quality and reliable results.

Maintain accurate and up-to-date records of all experiments and findings.

Assist in troubleshooting equipment and experimental problems.

B.S. in a biology discipline (Biology, Neuroscience, Bioengineering), 0-2 years of industry experience

Experience in mammalian cell culture

Experience in DNA/RNA extraction, PCR/qPCR, ELISA, western blot, immunostaining

Effective verbal and written communication skills relating to colleagues and associates inside and outside the organization.

Maintain cell lines (hiPSCs/HEK/Glia cell) with sterile techniques.

Support and collaborate with scientists, labs, vendors, and industry experts to ensure the completion of tasks/projects.

7. Assists investigator with correspondence with IRB. (essential)

4. Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.

3. Potential exposure to adverse environmental conditions

o Several times a month: Radiation-irradiator possible.

Experience performing molecular, biochemical, and cell biology techniques, including PCR, qPCR, RT-PCR, gel electrophoresis, cloning, nucleic acid purification etc.

Excellent communication skills, both verbal and written.

Knowledge of Microsoft Office products.

Assist in experimental design and independently conduct scientific experiments for product development, performance troubleshooting, and protocol optimization

Develop and write project protocols and methodology for developed research components.

Discuss and analyze experiments with the Principal Investigator

Assist in the monitoring and resolution of data discrepancies resulting from discrepancy listings generated from clinical data management

Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred

Follow up with outstanding documentations from clinical sites to complete site qualification

Manage site communications, generate site and patient reports and queries, and verify reports prior to distribution to clinical sites and sponsors

Phantom data analysis and data entry

Ensure IQC data is collected and maintained according to applicable SOPs and/or study protocol requirements

May train users on the operation and data management of research equipment.

Collects, compiles, and analyzes research data.

Prepares, collects, evaluates, and verifies samples and supporting records for experiments.

Uses statistical methods and relational databases to analyze data sets.

Prepares or assists with preparing reports of research findings.

Assists with planning, developing, coordinating, and administering research projects.

4. Organizes and manages general office tasks.

Work Arrangement (final schedule to be determined by the department/hiring manager): Onsite

2. Handles confidential information such as employee personnel records and other literature or correspondence.

3. Initiates, prepares and processes administrative documents.

6. Perform other duties as assigned.

(Hourly Rate: $15.00 - $22.75)

Review education and training experience with line manager and complete identified training needs within designated time period.

*Basic knowledge of site management and clinical monitoring for clinical research studies

Maintain job knowledge and skills through independent self-study.

OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Perform assessment of site personnel and facilities for study conduct through feasibility and site telephone qualification

Experience with data management in a research setting, including but not limited to tools such as REDCap or Qualtrics.

Please review the Benefits Brochure for some information on our benefits offerings.

Help maintain and manage datasets, and maintain clear and detailed documentation necessary to maintain databases and analyses.

Manage multiple research projects’ data collection timelines to keep projects on track to meet goals.

Experience with data collection with autistic individuals and/or their families, broadly defined.

Experience conducting engagement or outreach activities with families, either in a clinical, research, school-based, or community setting.

Understand and apply applicable corporate and divisional SOPs. Maintain knowledge of relevant QSR and safety requirements.

Demonstrate working knowledge of basic technical theories and principles within area of expertise for routine tasks.

Develop knowledge and understanding of GxP and related regulations and guidance.

Bachelors degree in a science-related field with 0-1 years experience

Possess relevant laboratory (chemistry)/technical, writing, and computer skills.

Employ appropriate techniques and methods to successfully conduct specific assignments within negotiated deadlines after receiving general instruction.

Participates in required training and education programs.

1-year Clinical Research Related Experience

Join our team and use your skills with an organization known nationally for excellence in research!

Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.

Evaluates and abstracts clinical research data from source documents.

Ensures compliance with protocol and overall clinical research objectives.

Conduct and oversee data collection and management; help generate study reports

Help prepare research materials (such as study protocols, questionnaires, educational materials, and data collection instruments)

High level of attention to detail, excellent organizational skills.

Excellent written skills, including academic writing skills. Outstanding interpersonal and verbal communication skills.

Strong working knowledge of Microsoft Office applications, specifically Word, Excel, PowerPoint, and Outlook.

Experience working with qualitative and quantitative data collection and analysis.

• Experience in mammalian cell culture is required.

• Excellent organizational and communication skills.

• Independently design and conduct experiments to improve AAV vector productivity and quality.

• Record experimental procedures and data in the Electronic Lab Notebook (ELN) in a timely manner.

• Contribute to a safe, efficient, and effective laboratory environment.

• Present findings/results at internal team meetings and write technical reports.

Minimum Qualifications – Education And Experience

Preferred Qualifications – Education And Experience

Work data entry into databases

Other projects or responsibilities as may be required.

Basic knowledge of immunological assays and protein purification is preferred

Knowledge of mammalian cell culture/ cell line maintenance; antibody purification and application is also preferred

Bachelor’s degree required; preferably in the biological sciences (or experience in biology research)

2+ years of sterile tissue culture experience preferred

CGMP experience preferred but not required

Cell culture and molecular biology skills are required

Experience with flow cytometry, functional assays, DNA, RNA and protein analysis is preferred

Previous experience with handling small animals (e.g. rodents) is preferred

Good organizational and time management skills

Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

To manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines

Perform other duties as assigned by management

To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements, as needed regionally

Good communication skills, oral and written

Knowledge of clinical research study processes, protocol management, and regulatory guidelines.

Proficiency in medical terminology and computer skills.

Strong attention to detail and excellent written and oral communication skills.

Ability to manage multiple deadlines and prioritize tasks effectively.

Minimum three years of experience in conducting clinical research studies or verifying clinical data.

Knowledge across multiple therapeutic areas, including blood and marrow transplant.