Internships

There are a variety of unpaid internship positions available in multiple departments, including QA/QC, Research & Development, and Business. If you are interested, please submit your resume for consideration, clearly indicating what type of position you are seeking.

Clinical Research Coordinator

The Clinical Research Coordinator (CRC) is responsible conducting clinical trials using Good Clinical Practice (GCP) under the direction of the Principal Investigator. The CRC will play a key role in the implementation of clinical trials for stem cell derived therapies for SMA, ALS, and SCI, and directly contribute to the gathering of good quality data.

Candidate will be responsible for coordinating Phase I-III clinical trials, recruiting patients for studies, performing clinical duties such as vitals, EKGs, phlebotomy, and any other clinical duties necessary to complete studies. The CRC will be responsible for assuring that trials are carried out in a manner consistent with all protocols and that there is smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.

Responsibilities

The CRC will assist in the scientific, technical and statistical aspects of clinical research design, compile clinical research data, provide statistical and graphic analysis of data, and participate in drafting clinical research abstractions, presentations, and papers for publication. The CRC will also:

• Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines.
• Be the primary contact for the study subjects and available for daily communication with study subjects and for communicating problems, questions and/or clarifications to stakeholders.
• Attend the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits by monitors or sponsor representatives.
• Establish study document binder to maintain complete and accurate records of all sponsor, site, CRO, IRB/IEC correspondence and regulatory documents pertaining to the study.
• Prepare source documents specific to the study. This includes study folders and subject information folders, as required by the study.
• Review approved regulatory documents from the IRB/IEC, checking for completeness.
• Set up a recruitment plan with Recruitment Services Supervisor. Oversees recruitment and works with appropriate personnel to make adjustments as needed.
• Meet with Recruitment Services Supervisor and Recruitment Specialists to instruct on protocol specific phone screening questionnaire and scheduling of potential subjects.
• Review subject screening forms prior to subject's appointment to verify screening eligibility.
• Comply with in-house and FDA documentation requirements.

Medical Director

The individual will provide clinical leadership to business development, regulatory strategy and interactions to ensure cross regional consistency. The medical director will develop a clinical strategy for disease programs to meet corporate goals and objectives, applicable regulatory requirements, Good Clinical Practices (GCPs) and Standard Operating Procedures (SOPs).

Responsibilities

The Medical Director will take a leadership role in planning the overall strategy for clinical drug product development, participate in determining the course of action necessary to meet the goals and objectives of specific projects and represent CSC research and development in outside discussions and medical scientific forums. The Medical Director will also:

• Participate in the planning, writing and review of clinical study reports, regulatory updates and submissions and assure their timely completion. Support regulatory fillings including INDs and NDA fillings.
• Design, prepare and initiate clinical study protocol and select vendors for clinical trials (CROs, central labs etc). Work on regulatory issues around approval from clinic
• Finalize protocols, and assure timely completion and quality and accuracy of study reports
• Develop and execute a plan for launching the study and ensure effective study design preparation, initiation and safe conduct of trials and conduct and quality interpretation of study results.
• Participate in the selection of clinical investigators, provide proper investigator profile for study, and assist in conducting investigator meetings.
• Complete clinical trials application, and organize, manage and direct the activities of the clinical team established to take primary responsibility for completing the clinical development project
• Work actively engaging with clients, direct and assist internal staff, CROs, and consultants as required
• Monitor progress against expectations on timeline
• Manage relationships with all the investigators and clinical sites
• In conjunction with clinical operations, oversee day to day operation of ongoing clinical studies, if necessary, visit selected sites to trouble shoot, train/retain staff.
• Accurately interpret and communicate clinical trials results orally or via written documents

Requirements

• M.D. degree and 3-5 years of hands-on experience in Phase I-III drug development in the Biotech and/or Pharmaceutical industry.
• Cell-based therapeutic development experience preferred.
• Experience monitoring clinical trials with appropriate knowledge of GCPs regulations.
• Excellent partnering skills; strong interpersonal skills and leadership abilities

Research Associate

We have an IMMEDIATE need for a highly competent and motivated research associate to be part of the multidisciplinary team that is responsible for the development of cutting edge stem cell derived products. The research associate will develop procedures, perform in-vitro studies, assays, and data analysis and provide feedback for refinement and optimization of products and processes.

Suitable candidates for this position must have previous experience in mammalian cell culture and molecular biology techniques, ideally with background in hESC culture. Projects require the ability to read and understand relevant scientific literature and an understanding of fundamental principles, theories and concepts in the area of stem cell research.

The candidate will have a significant amount of responsibility and require a high degree of independence to help ensure the efficient day-to-day running of the laboratory, including: maintenance of cell cultures, ensuring that laboratory supplies are adequately stocked and that equipment is suitably maintained and repaired. He/she will be responsible for making detailed observations, analyzing data, interpreting results and preparing technical reports, summaries and new protocols.

The candidate must be a self-starter and work with little instruction, have a collaborative and inquisitive nature, and must possess excellent organizational, problem-solving and verbal/written communication skills.

Responsibilities

• Use technical expertise in laboratory procedures to perform in vitro experiments and well as maintain cell cultures.
• Discuss results with team and provide input for planning future studies and for modifications.
• Assist research and identification of novel and new methods that may be used to address the problems and technical hurdles.
• Record, calculate, and maintain detailed records of experimental data in accordance with GLP. Input data in to database and derive reports.
• Review, revise, and write SOPs as necessary.
• Ensure all necessary laboratory supplies are on hand and ready for use.
• Maintain, clean, and ensure proper calibration of laboratory equipment.
• Attend team meetings and internal group research meetings and make contributions to research projects in progress.
• Present data internally at departmental meetings.

Requirements

• B.S. or M.S. in biological sciences
• Three years or more of experience in hands-on mammalian cell culture required
• Knowledge and demonstrated proficiency in biochemical, molecular, cellular and immunological methods required
• Interest and experience working in early stage development of cutting edge biotechnology products
• Strong work ethic, methodical approach to new challenges
• The candidate should have strong organizational and communication skills required to assist and collaborate with multidisciplinary groups of technology innovators in a dynamic team environment.
• GLP, GCP, and GMP experience a plus
• Must be able to work independently and with minimal supervision
• Must work weekends occasionally as necessary to accommodate maintenance of cells grown in culture.
• Must be fluent in English and proficient in Microsoft Office suite including Excel, Word and PowerPoint.
• Able to work in fast paced environment and independently manage multiple, complex assignments, at times under pressure and with tight deadlines