Clinical Research Associate jobs in Chattanooga, TN

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.