Sr. Clinical Research Associate

BioBridge Global - San Antonio, TX2.6

Full-time
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Our organization is unique in that we are a nonprofit community resource that saves lives by working with volunteer donors to provide the highest quality blood & tissue components to patients. By using cutting-edge technology, our team of dedicated professionals has helped save hundreds of thousands of lives for more than 35 years. Over 200,000 components of life-saving blood and tissue from volunteers throughout South Texas are collected and tested each year. We are internationally recognized for the quality of our services and research. Donors are essential because patients are in constant need of blood. blood components, and/or tissue. It's about life! Share our excitement and join our team!

GenCure, a subsidiary of BioBridge Global, applies advances in regenerative medicine to help heal patients suffering from trauma, disease or the aging process. Using processed tissue and cell-based therapies, GenCure works to connect needs with solutions. GenCure is both a direct supplier to healthcare providers and a partner with commercial and non-profit organizations providing regenerative medicine treatments to patients.

General Summary

Responsible for monitoring and evaluating clinical studies to ensure ongoing compliance with the Institutional Review Board (IRB) and all applicable regulations. Responsible for ensuring data for trial is being maintained accurately. Prepare IRB submissions and ongoing reviews. Prepare adverse event or protocol deviation reports within the time required. Responsible for assessing risks associated with clinical research protocols to ensure compliance and donor/patient safety. Ensure compliance to the BioBridge Global (BBG)/GenCure quality systems, applicable regulations (e.g., FDA, EU), and applicable accreditation standards (e.g., AABB, AATB, ISO). Work in conjunction with operational leaders and program/project managers to enhance organizational performance by utilizing proven methodologies to deliver breakthrough solutions resulting in cost savings, revenue enhancement and quality improvement. Assist leaders with identifying evidence-based strategies.

Facilitate decision-making and timeline achievement while holding self and others accountable. Act as a key contributor to project teams, such as product development teams and special projects.

Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE).

Provide world class customer service by capturing and being responsive to the voice of the customer (including donors) through established feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes.

Must have a valid driver's license and be at least 21 years old with a good driving record to meet organization driving standards.

Major Duties and Responsibilities

Essential Tasks

Acts as primary site contact for Quality Assurance (QA) aspects of research/clinical studies that GenCure/BBG conducts or for which GenCure provides contracted services. As a key contact with Sponsors, cultivates productive relationships by facilitating study conduct at GenCure/BBG, resolving challenges, identifying opportunities, and coordinating across the organization to achieve study timelines.

Ensure research/clinical studies remain compliant with IRB and applicable regulations.

Collects, reviews, and processes regulatory documents.
Prepares IRB protocol submissions, IRB continuing review reports.
Provides consenting and IRB training for GenCure/BBG staff, as well as staff of supporting hospital partners engaged in the study.
Prepares and evaluates adverse event or protocol deviation reports within the time required.

Assesses and investigates issues per BBG Corrective & Preventive Action procedures.

Performs study monitoring activities ensuring compliance with Protocol, Site Monitoring Plan, Sponsor/GenCure SOPs, and as applicable ICH-GCP, Local Laws & Regulations, to include – but not limited to the following:

All applicable employees are trained on each Protocol and Human Subject Protection.
Consents are performed and documented appropriately
Participant charts for compliance with protocol and internal SOPs.
Data entry and aggregation against study parameters to ensure accuracy.
Develops and implements study-specific monitoring tools.

Participates in regulatory and sponsor audits.

Supports electronic data capture (EDC) or Clinical Trial Management System (CTMS), when applicable, monitoring for completeness and consistency, and addressing queries.

Conducts/oversees QA review for release of donor charts for Cord Blood and Cellular Therapy collections under study protocols.

Coordinates research requests to GenCure/BBG from external organizations, ensuring appropriate information is provided to the BBG research committee.

Maintains tracking tools for GenCure research and clinical study activities.

Contributes in the design of GenCure/BBG research and clinical studies as assigned to include study protocols, amendments, inclusion/exclusion criteria, informed consent forms, study manuals, study reports.

Gains a working knowledge of the diagnostic/therapeutic fields and investigational articles being studied.

Develops and implements SOPs supporting GenCure research and clinical study activities and associated QA procedures; collaborates with interfacing departments on process flows, roles, and responsibilities.

Participate in team oriented work projects for the development and implementation of strategic initiatives, validations, process improvements, and Standard Operating Procedures (SOPs).

Participate in the development of divisional plans, project plans, procedures and guidelines in coordination with management.

Work with the quality management teams across BBG to support all R&D work as applicable to protocol/process monitoring, IRB reporting/management, and participant safety.

Performs other duties as assigned.

Non-Essential Tasks

Develop relationships with external customers, researchers, and biotech companies and conduct educational presentations to increase participation with stem cell/clinical research projects.

Education
Requires a Bachelor’s Degree from an accredited four-year college or university. The required major is in Science, Health related, or equivalent.

Prefer a Master's Degree from an accredited college or university.

Licenses and/or Certifications

Texas Operators Driver’s License

Certified Clinical Research Associate (SoCRA or ACRP) preferred or must be able to sit for certification exam.

Experience
Requires seven or more years Research/Clinical Trials experience.

Must have completed a minimum of three years experience performing CRA essential duties as described by the Association of Clinical Research Professionals (ACRP).

Prefer five or more years of FDA regulated experience. Prefer two or more years in quality management experience.

Prefer two or more years blood bank, tissue bank, or marrow program experience.

Knowledge
Must maintain a knowledge of cGMP (current Good Manufacturing Practices), cGTP (current Good Tissue Practices), and CLIA regulations.

Must have and maintain Clinical Research Associate Certification.

Must have a comprehensive working knowledge of the principles of clinical trial conduct in accordance with ICH/GCP and other related regulations and guidance.

Skills
Must be capable of operating motor vehicles in all types of weather conditions.

Must have strong computer skills.

Must have excellent written and oral communication skills.

Must be adept in the development of quality compliance procedures.

Abilities
Must be a self-starter and self-directed worker.

Must be able to prepare various reports to include tracking and trending reports for donor/patient collections, adverse events/reactions and protocol deviations.

Must be able to work in teams to reach goals within timelines.

Must be neat in appearance and well groomed.

Must be professional, organized, detail oriented, communicative, and have the ability to greet the public in a friendly and courteous manner.

Must have the ability to explain complex concepts to non-technical individuals.

Must keep all donor/subject information confidential.

Working Environment
Works in well-lighted, air-conditioned and heated vehicle or office environments, but may work in confined spaces and non-climate controlled conditions such as outdoor events. May be exposed to body fluids, blood borne pathogens, electrical and chemical hazards, and other conditions common to a full service blood center. May be required to work at any time of the day, evening or night during the week or weekend to include being on-call. Ability to use personal motor vehicle for company business required.

Physical Requirements

Must be able to drive on behalf of the organization.

Will sit, stand, walk, and bend during working hours.

Requires to reach, lift and carry up to 20 lbs.

Requires manual and finger dexterity and eye-hand coordination.

Requires normal or corrected vision and hearing corrected to a normal range.

We invest in our people by offering competitive compensation, excellent benefits, and the opportunity to work with the first blood center in America to receive the ISO 9002 accreditation!

All Full Time Positions Qualify for an Affordable and Competitive Benefits Package to include:

  • Competitive salary
  • 100% Employer Paid Life Insurance
  • Variable Compensation Plan
  • 100% Employer Paid Long-term Disability Plan
  • Paid Time Off (PTO)
  • 100% Employer Paid AD&D
  • Extended Illness Benefits (EIB)
  • 100% Employer Paid Employee Assistance Program
  • Shift Differentials
  • Group Health Medical Plan w/prescription coverage
  • Paid Holidays
  • Variety of Voluntary Supplemental Insurances
  • Leaves of Absence
  • Voluntary Dental Coverage
  • Educational Assistance Program
  • Voluntary Vision
  • Professional Development Plan (PDP)
  • 100% Employer Paid Pension Plan
GenCure, a subsidiary of BioBridge Global, is proud to be an Equal Opportunity Employer committed to providing employment opportunities to minorities, females, veterans, and disabled individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, genetic data, sexual orientation, gender identity, or any other legally protected characteristics. For more information about your EEO rights as an applicant under the law, please click here. GenCure maintains a Tobacco & Drug-Free Workplace.