Clinical Research Associate jobs in Birmingham, AL

S
Study Director 2 - Pre-clinical Infectious Disease Research
  • Southern Research
  • Birmingham, AL FULL_TIME
  • STUDY DIRECTOR 2 - PRE-CLINICAL INFECTIOUS DISEASE RESEARCH
    General Summary
    The position functions as study director and subject matter expert on commercial and government contracts and has oversight of the scientific elements of projects to ensure successful completion and/or implementation in the area of emerging viral infectious diseases. The study director 2 monitors project work for timely completion, deliverables, and quality standards. Individuals in this role work independently on studies; compiling and evaluating data, assembling study files and reports for publication or to sponsor; provide instruction to other members of the project team; and collaborate with other senior members of the staff on projects/research. The study director 2 acts as a key point of scientific control for our clients and will often interact with clients. The position works closely with assigned project team members and related management for studies. The study director 2 is fully trained in the position’s key responsibilities as it applies to work areas and may require training on new processes as they arise. May provide training to others as necessary, to conduct similar project execution. Position serves as technical leads for project proposals.
    Essential Duties and Responsibilities
    • Performs role of study director (SD) and scientific subject matter expert (SME) on infectious disease projects.
    • Must have at least 6 months experience as an In Vivo study director.
    • Performs in vivo and in vitro experimental study design for vaccines and therapeutics and interacts with clients.
    • Drafts protocols, amendments, and departmental notifications for projects; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
    • May create and maintain the study file (electronic) and/or study binders (hard copy).
    • May create and maintain the ACUP and BPR as needed.
    • Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and conducts pre-study meetings.
    • Ensures that the protocol and/or scope of work reflects the contract.
    • Identifies and incorporates exceptions to GLP conduct into GLP study protocols as applicable (e.g., systems/processes that are not validated).
    • Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses.
    • Completes review of Standard Operating Procedures (SOPs) associated with study conduct and incorporates appropriate language into the protocol when necessary to provide detail on procedures not included.
    • Reviews contract for use in execution of studies and proactively notifies Project Manager of any issues.
    • Sets up or requests the creation of Provantis study files for applicable studies.
    • Performs review of Provantis study setups prior to providing approval for use.
    • Works closely with the scheduling staff and department leadership to ensure project work is scheduled appropriately to meet customer timelines.
    • Collaborates with project team members and related management to support study execution.
    • Submits requisitions as necessary, Communicates and approves purchase requisitions as necessary.
    • Provides coverage for client-facing activities.
    • Performs/documents study inspections and presents findings as applicable.
    • Prepares or reviews data for processing and reporting; ensures quality control is performed and corrections are made in accordance with deadlines.
    • Reviews software programs, forms, and/or data for missing, inaccurate, or improbable results and for adherence to regulatory and/or client requirements; may aid in resolving data collection problems as needed.
    • Assists in preparation of study reports or contributing scientist reports.
    • Assists in the training of others as applicable.
    • Authors, updates, and/or reviews area-specific Standard Operating Procedures (SOPs), ensuring that SOPs reflect current practices.
    • May be asked to serve as system administrator, assist on validation teams, ad hoc committees, represent at internal meetings, or contact sponsors regarding study specific issues.
    • Works closely with study coordinator and/or project manager as technical SME on assigned projects and will interface with client’s scientific staff as appropriate.
    • Develops assays; completes study designs for infectious diseases in vitro and/or in vivo studies.
    • Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
    • Supports troubleshooting assay issues in validation and sample analysis.
    • Reviews data from sample analyses and interpret Contributing Scientist Reports (CSR).
    • May participate in proposal generation and perform scientific/technical review.
    • Follows GLP practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
    • Performs all work tasks following laboratory safety requirements including A/BSL-3 and select agent.
    • Ensures compliance to all regulatory and safety requirements for work with select agents.
    • Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, and study protocols.
    • Participates in required select agent training as appropriate. Conducts or oversees virology studies and assay development/validation experiments.
    • Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
    • Executes IR&D studies for new pipeline development.
    Requirements/Minimum Qualifications
    • PhD in life sciences discipline or DVM with at least 2 year’s relevant experience or Master’s degree in life sciences with 8 years’ relevant experience or Bachelor’s degree in life sciences with 11 year’s relevant experience.
    • Have a recognized standing in their specialty with strong publication record and are known for their innovation and creativity in areas supporting the organization’s mission.
    • Broad experience in infectious disease research with in vitro and in vivo models is a must.
    • Prior experience with Immunogenicity and efficacy testing in animal models such as mice, ferrets, hamsters, monkeys
    • Proficient in assay development methodologies.
    • Ability to work in A/BSL-1,2, and 3 environments
    • Prior experience with A/BSL-1,2 and 3 and handling of select agent is preferred.
    • Ability to coordinate the work of others to meet project objectives and deadlines.
    • Ability to interact with others in a cooperative, persuasive, and tactful manner.
    • Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.
    • Prior demonstrated experience in in vivo studies for evaluating vaccines and therapeutics.
    • Demonstrated work experience and competence in executing in vivo and in vitro studies in a GLP-compliant environment.
    • Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
    • Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
    • Ability to conduct and manage meetings/trainings effectively.
    • Working knowledge of or the ability to learn and utilize specialty software applications (e.g., Edstrom, laboratory information management systems, etc.)
    • Must be eligible to work in the United States without employer sponsorship.
    Organizational Core Values
    Cultivating human connection – putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world’s most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
    Operating with precise execution – measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
    Harnessing relentless curiosity – our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
    Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment. We don’t compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
    Work Environment & Conditions
    This position works in a laboratory environment (A/BSL-1, 2, & 3) and requires the use of personal protective equipment (PPE) including (but not limited to):
    • Eye protection (Safety glasses and/or full-face shield)
    • Respirator (varies based on tasks and barrier requirements)
    • Tyvek/scrub suits
    • Nitrile (or equivalent) gloves (varies based on tasks)
    • Hearing protection (varies based on tasks)
    Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.
  • Just Posted

A
Patient Recruiter
  • Alcanza Clinical Research
  • Birmingham, AL FULL_TIME
  • Patient RecruiterDepartment: MarketingEmployment Type: Full TimeLocation: Accel Research Sites - Birmingham, ALReporting To: Samantha MackerprangDescriptionAlcanza is a growing multi-site, multi-phase...
  • 2 Days Ago

S
Associate Director, Biosafety
  • Southern Research
  • Birmingham, AL FULL_TIME
  • Associate Director, Biosafety General Summary This position is responsible for leading the Southern Research biological safety program. The Associate Director of Biosafety (ADB) serves as the Biosafet...
  • 6 Days Ago

U
CLINICAL RESEARCH COORDINATOR II
  • UAB Health System
  • Birmingham, AL OTHER
  • The University of Alabama at Birmingham (UAB), Department of Med - Endocrinology, Diabetes & Metabolism, is seeking a Clinical Research Coordinator II. Housed within the Division of Endocrinology, Dia...
  • Just Posted

U
CLINICAL RESEARCH ADMINISTRATOR I
  • University of Alabama at Birmingham
  • Birmingham, AL FULL_TIME
  • Description The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Clinical Research Administrator I. The ideal candidate must be able to effectively interface ...
  • 6 Days Ago

U
CLINICAL RESEARCH COORDINATOR I
  • UAB Health System
  • Birmingham, AL OTHER
  • The University of Alabama at Birmingham (UAB), Department of Epidemiology, is seeking a Clinical Research Coordinator I. The individual will monitor blood-drawn results and detect and report any unusu...
  • 1 Month Ago

Filters

Clear All

  • Filter Jobs by companies
  • More

0 Clinical Research Associate jobs found in Birmingham, AL area

W
Registered Nurse (RN) - MedSurg Float
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Facility: Kennestone Hospital How would you like to work in a place where your contributions and ideas are valued? A pla...
  • 4/24/2024 12:00:00 AM

M
Entry Level Healthcare Sales Representative
  • Medasource
  • Birmingham, AL
  • Launched in 2000, Eight Eleven Group committed to 100% organic growth, exclusively promoting from within, while always k...
  • 4/23/2024 12:00:00 AM

W
RN MedSurg
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Facility: Spalding Medical Center Job Summary: The RN Clinical Nurse is a proactive member of an interdisciplinary team ...
  • 4/22/2024 12:00:00 AM

W
Internal Agency Virtual Interview Day - (4/24/24) Acute Care/MedSurg 7a-7p & 7p-7a Shifts
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Job Summary: The Internal Agency RN Clinical Nurse- Acute Care is a proactive member of an interdisciplinary team of lic...
  • 4/22/2024 12:00:00 AM

W
Registered Nurse (RN) MedSurg Cardiac Telemetry- Full-Time Night Shift
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Facility: North Fulton Hospital Job Summary: Wellstar North Fulton Hospital has an opportunity for a Registered Nurse (R...
  • 4/22/2024 12:00:00 AM

W
Registered Nurse (RN)- Neuro MedSurg - Full-Time Night
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Facility: North Fulton Hospital Overview Wellstar North Fulton Hospital has an opportunity for a Registered Nurse (RN) -...
  • 4/22/2024 12:00:00 AM

W
Assistant Nurse Manager - MedSurg- Cardiac Telemetry - Full-Time Various Shifts
  • Wellstar Health System, Inc.
  • Birmingham, AL
  • Facility: North Fulton Hospital Job Summary: Wellstar North Fulton Hospital has an opportunity as Assistant Nurse Manage...
  • 4/22/2024 12:00:00 AM

M
Entry Level Account Executive
  • Medasource
  • Birmingham, AL
  • Launched in 2000, Eight Eleven Group committed to 100% organic growth, exclusively promoting from within, while always k...
  • 4/21/2024 12:00:00 AM

Birmingham (/ˈbɜːrmɪŋhæm/ BUR-ming-ham) is a city located in the north central region of the U.S. state of Alabama. With an estimated 2017 population of 210,710, it is the most populous city in Alabama. Birmingham is the seat of Jefferson County, Alabama's most populous and fifth largest county. As of 2017, the Birmingham-Hoover Metropolitan Statistical Area had a population of 1,149,807, making it the most populous in Alabama and 49th-most populous in the United States. Birmingham serves as an important regional hub and is associated with the Deep South, Piedmont, and Appalachian regions ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$63,808 to $84,279
Birmingham, Alabama area prices
were up 1.3% from a year ago

Clinical Research Associate in Bound Brook, NJ
Create, test and maintain SAS programs for clinical studies according to departmental standard procedures.
December 31, 2022
Clinical Research Associate in Cleveland, OH
Operates effectively as a team member or leader with an understanding of team dynamics.
December 23, 2022
Clinical Research Associate in Laguna Hills, CA
Meet with staff on an annual basis to develop and implement career goals in order to encourage and promote professional growth and development.
May 06, 2023