Clinical Research Manager jobs in Chattanooga, TN

Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Clinical Research Associate
  • Theradaptive
  • Chattanooga, TN FULL_TIME
  • Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair.

    Our lead therapeutics are in the following indications:

    • Spinal Fusion
    • Long Bone Repair
    • Osteochondral Repair
    • Dental and Facial Bone Repair
    • Immuno-Oncology

    We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.

    POSITION SUMMARY:

    We are seeking an experienced Clinical Research Associate (CRA) to be responsible for initiating and monitoring clinical trial sites. The CRA will participate in the conduct of clinical trials to test drugs or devices for their effectiveness, risks, and benefits to ensure their safety for intended use.

    The successful candidate will work on novel combination products, devices and drugs and will typically be involved in the planning and execution stages of the clinical trial, including tracking site visits.

    Clinical trials may be carried out at various stages or phases and include trials on healthy humans, trials on patients with a disease, and studies conducted after the launch of a new product to monitor safety and side effects.

    RESPONSIBILITIES

    Tasks vary depending on the product under study and the investigational site. Typically:

    • Develop and write trial protocols along with the Clinical Team (outlining purpose and methodology)
    • Present trial protocols to potential study sites
    • Complete and monitor data collection forms, known as case report forms (CRFs)
    • Oversee contract negotiations and budgeting at research sites as well as site initiations and close outs
    • Direct matters for the Clinical Project Manager to coordinate with the ethics committee(s)
    • Assist in managing regulatory authority applications and approvals that oversee the research and marketing of new and existing products
    • Identify and assess the suitability of facilities to use as the clinical trial site
    • Assist to identify/select investigator(s) who will be responsible for conducting the trial at the trial site
    • Liaise with doctors, consultants, or investigators on conducting the trial
    • Set up the trial sites - ensuring each center has the trial materials, including the trial product often known as the investigational medicinal product (IMP)
    • Train the site staff on trial-specific industry standards and requirements
    • Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
    • Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
    • Collect completed CRFs from hospitals and general practices if not in the Electronic Data Capture (EDC); EDC entries to be verified against source records
    • Write visit reports and file and collate trial documentation and reports in accordance with SOPs
    • Meet with team members to discuss ongoing trials, results and any trends or adverse events
    • Ensure all unused trial supplies are accounted for
    • Close down trial sites on completion of the trial and resolve any data queries
    • Discuss results with a medical statistician, who writes technical trial reports
    • Archive study documentation and correspondence in trial TMF
    • Prepare final reports and occasionally manuscripts for publication

    QUALIFICATIONS:

    • Bachelor’s degree or minimum of 21 hours college credit in life sciences, medical sciences, or nursing is required
      • Relevant subjects include anatomy, biochemistry, biology, biomedical science, chemistry, immunology, microbiology, molecular biology, pharmacology or pharmacy, physiology, and toxicology.
      • Additional experience in lieu of education may be acceptable
    • Four to five years of experience working as a CRA or in a similar capacity is required
    • Experience in contract negotiations and budgeting at research sites as well as site initiations and close outs
    • A thorough, working knowledge of Good Clinical Practices is required
    • Excellent written, verbal, and interpersonal communication skills
    • The ability to build effective relationships with trial center staff and colleagues
    • The ability to motivate others
    • Strong customer focus, presentation, and project management skills
    • An excellent grasp of numeracy and a keen eye for detail
    • The ability to multitask and think on your feet with a flexible and adaptable approach to work
    • Organizational, IT and administrative skills - the job involves a lot of documenting and recording information through computerized processes, such as clinical trial management systems and electronic data capture
    • A clean driving license may be required for travel between trial sites and your office
    • Skills in an additional language, particularly any European ones, may also be useful for roles abroad
    • Experience in Orthopedic trials is preferred

    LOCATION, TRAVEL, AND SCHEDULE

    • Residing in a location that is commutable to the Chattanooga, TN area is desired
    • This is a full-time role that will be a mixture of desk-based work and site visits. The role will operate entirely remotely when not engaged in site visits
    • This role will require frequent travel throughout the US as well as some international travel.
    • This position will involve close collaboration with Theradaptive partners.  Our partner companies have varying work schedules, and some evening work will be expected, although weekend or shift work will be uncommon

    https://www.theradaptive.com

    Theradaptive is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.

  • 15 Days Ago

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Permanent Clinical Research Coordinator Registered Nurse
  • Aya Healthcare
  • Rome, GA FULL_TIME
  • Aya Healthcare has an immediate opening for the following position: Clinical Research Coordinator Registered Nurse in Rome, Georgia. This is a 104 week contract position that requires at least one yea...
  • 18 Days Ago

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Clinical Research Physician / Principal Investigator - PT hours (Gastroenterology)
  • M3USA
  • Chattanooga, TN FULL_TIME
  • Company DescriptionM3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceut...
  • 14 Days Ago

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CLINICAL MANAGER (NE)
  • Adoration Home Health and Hospice
  • McMinnville, TN FULL_TIME
  • Our Company: Adoration Home Health and Hospice Overview: The Clinical Manager is responsible for the quality of care provided for patients in their area of responsibility. Collaborates with other disc...
  • Just Posted

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Clinical Pharmacy Manager
  • Shields Health Solutions
  • Chattanooga, TN FULL_TIME
  • At Shields, we pride ourselves on our culture of inclusion and kindness and the difference we make in patients' lives every day. We are tremendously proud to be certified as a 'Great Place to Work' tw...
  • 8 Days Ago

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RN Clinical Manager
  • CenterWell Home Health
  • Bridgeport, AL FULL_TIME
  • Become a part of our caring community and help us put health first The Clinical Manager coordinates and oversees all direct care patient services provided by clinical personnel.Develops, plans, implem...
  • 26 Days Ago

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0 Clinical Research Manager jobs found in Chattanooga, TN area

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Director - HIM
  • Acadia Healthcare
  • Chattanooga, TN
  • PURPOSE STATEMENT: Responsible for the overall leadership and management of the Health Information Management Department...
  • 3/29/2024 12:00:00 AM

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Travel Physical Therapist - Explore ATI
  • Ati Physical Therapy
  • Chattanooga, TN
  • Overview: As a licensed Physical Therapist, you are responsible for the evaluation and treatment of patients, establishi...
  • 3/29/2024 12:00:00 AM

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RN Cardiac Step Down - PRN
  • Parkridge Medical Center
  • Chattanooga, TN
  • Description Introduction Are you looking for a place to deliver excellent care patients deserve? At Parkridge Medical Ce...
  • 3/28/2024 12:00:00 AM

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Perfusionist - Full-Time - $30,000 Sign on bonus
  • Erlanger Health
  • Chattanooga, TN
  • $30,000 Sign on Bonus Job Summary: The perfusionist will provide perfusion services under the direct or indirect supervi...
  • 3/28/2024 12:00:00 AM

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RN Cardiac Step Down - PRN
  • HCA
  • Chattanooga, TN
  • Introduction Are you looking for a place to deliver excellent care patients deserve? At Parkridge Medical Center we supp...
  • 3/28/2024 12:00:00 AM

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PCU Clinical Nurse Coordinator
  • Parkridge Medical Center
  • Chattanooga, TN
  • Description Introduction Are you looking for a place to deliver excellent care patients deserve? At Parkridge Medical Ce...
  • 3/26/2024 12:00:00 AM

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PCU Clinical Nurse Coordinator
  • Parkridge Medical Center
  • Chattanooga, TN
  • Description Introduction Are you looking for a place to deliver excellent care patients deserve? At Parkridge Medical Ce...
  • 3/26/2024 12:00:00 AM

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Lead Certified Tumor Registrar
  • CommonSpirit Health
  • Chattanooga, TN
  • Overview: CHI Memorial Hospital now part of CommonSpirit Health formed between Catholic Health Initiatives (CHI) and Dig...
  • 3/25/2024 12:00:00 AM

According to the United States Census Bureau, the city has a total area of 144.6 square miles (374.4 km2), of which 137.1 square miles (355.2 km2) are land and 7.4 square miles (19.2 km2), or 5.12%, are water. The most prominent natural features in and around Chattanooga are the Tennessee River and the surrounding mountains. The city is nestled between the southwestern Ridge-and-valley Appalachians and the foot of Walden's Ridge; the river separates the ridge from the western side of downtown. Several miles east, the city is bisected by Missionary Ridge. The Tennessee River is impounded by th...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Manager jobs
$89,253 to $118,254
Chattanooga, Tennessee area prices
were up 1.3% from a year ago

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