Senior Clinical Research Associate

Biolinq; San Diego (CA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Biolinq is seeking a Senior Clinical Research Associate (Sr CRA) to support study planning, site training, and closeout of compliance actions. The Sr CRA is a clinical-operations lead and the main contact for clinical sites from initiation through closeout.

Required: a STEM degree (BA/BS or MS) with 2–5 years related experience in clinical research, knowledge of Good Clinical Practice (GCP) and HIPAA, and strong communication.

Qualifications

• Bachelor’s (BA or BS) in a STEM field and 3–5 years of related experience, or Master’s in STEM and 2–4 years related experience.
• Knowledgeable in Good Clinical Practice guidelines and regulations for conducting human clinical studies.
• Experience complying with HIPAA and managing Protected Health Information (PHI).

Responsibilities

• Serve as a team member in all aspects of clinical study execution.
• Provide on-site lead clinical support from execution to compliance.
• Act as a resource for protocol and study logistics questions.

Skills

Clinical research experience

Leadership

HIPAA knowledge

Communication skills

Problem solving

Education

STEM degree (BA/BS or MS)

Job description

Job Type

Full-time

Description

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The only official source for actual Biolinq job postings/openings is at www.biolinq.com/careers. While other job sites (such as LinkedIn, Indeed or Glassdoor) may pull from Biolinq’s careers web page, you should visit www.biolinq.com/careers to verify the accuracy of the openings found on third party web sites.

About the Company

Biolinq is a venture-backed digital health company developing a wearable biosensor platform that measures biomarkers important to the management of many clinical conditions including diabetes. This dynamic role is a part of a team of engineers and scientists developing a novel intradermal biosensor technology and the associated software data extraction and rendering SDK that will transform the way people manage their metabolic health.

Job Description

Senior Clinical Research Associate (Sr CRA) is responsible for assigned tasks to support study planning, site training, following up and closing out open compliance related action items. A Sr CRA is expected to take a leadership role within the Clinical Team to be a resource for junior team members and main point of contact for Clinical Sites. This role is expected to foster and maintain a good working relationship with clinical sites from site identification, initial contact, site initiation through site close out.

Duties and Responsibilities

• Serve as a team member in all aspects of clinical study execution


• Provide on-site lead clinical support from execution to compliance


• Serve as an accessible resource for clinical site to answer protocol and study logistics related questions


• Act as a clinical study monitor for in-house and external study protocols


• Maintain organization systems for tracking site progress throughout clinical trial


• Learn and consistently complete work that is in line with Biolinq Clinical Procedures.


• Develop clinical study materials with management input.


• Run study-related meetings and provide training to study staff and subjects at clinical sites


• Provide support to management for preparing documentation, reports, and presentations


• Conduct monitoring visits for Biolinq sponsored studies including completion of monitoring report and oversee any action items to completion


• Assist with distribution of regulatory documents and the maintenance of trial master files


• Assist with departmental audits of clinical studies and procedures


• Perform scribe function during clinical meetings and produce meeting minutes for management review


• Collaborate effectively with peers and leadership across departments


• Other duties as assigned

Requirements

• Bachelor’s (BA or BS) degree in a STEM discipline, and 3-5 years of related experience or Master’s degree in a STEM discipline, and 2-4 years of related experience


• Certification and/or Training in Clinical Research preferred.


• Knowledgeable in Good Clinical Practice guidelines and regulations for conducting human clinical studies


• Experience complying with Health Insurance Portability and Accountability Act (HIPAA) and the ability to manage Protected Health Information (PHI)


• Independently completes routine work with management input on tasks of greater complexity.


• Provide leadership to junior team members of Good Clinical Practice.


• Works on moderately complex problems where analysis of situations or data requires evaluation


• Exercises judgment within defined procedures and practices to determine appropriate action


• Demonstrates technical proficiency


• Personal computer skills, including proficiency in word processing, spreadsheet, and electronic databases


• Must maintain good communication skills with patients and health care professionals


• Ability to engage in continuous learning and self-development

Working Conditions

• Position will be preferably based at Biolinq Headquarters (non-remote) or hybrid/remote as approved


• General office, Physician offices, Medical Clinics, Hospitals, and Laboratory


• Travel required up to 70% and will be based on number of clinical studies being conducted


• Hours of work may be outside of the traditional M-F work week

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee may occasionally lift/or move up to 15 pounds.

BENEFITS

Medical, dental, vision, health savings account, flexible spending account, life and long-term disability insurance, 401(k) plan, holidays, and PTO.

Equal Employment Opportunity (EEO)

At Biolinq we fully subscribe to the principles of Equal Employment Opportunity. It is our policy to provide employment, compensation, and other benefits related to employment based on qualifications, without regard to race, color, religion, national origin, age, sex, veteran status, genetic information, disability, or any other basis prohibited by federal, state or local law. In accordance with requirements of the Americans with Disabilities Act and applicable federal, state and/or local laws, it is our policy to provide reasonable accommodation upon request during the application process to applicants in order that they may be given a full and fair opportunity to be considered for employment. As an Equal Opportunity Employer, we intend to comply fully with applicable federal, state and/or local employment laws and the information requested on this application will only be used for purposes consistent with those laws. To the extent required by applicable law, The Company maintains a smoke- free workplace.

As part of our efforts to ensure fair and equal pay based on merit, Biolinq supports pay transparency internally and during the recruitment process. The U.S. base salary range reasonably expected to be paid for this role is: $100,000 to $130,000 per year. We may ultimately pay more or less than the posted range. Actual compensation packages are commensurate with experience and based on a variety of factors that are unique to each candidate including, but not limited to: skill set, depth of experience, education, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries for the job across the U.S. The total compensation package for this position may also include an annual performance bonus and/or other applicable incentive compensation plans. Biolinq also offers a comprehensive package of benefits including paid time off (vacation, holidays, sick time, parental leave), medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans and any written agreement between the parties. Your recruiter can share more about the total compensation package during the hiring process.

Please note: The information contained herein is not intended to be an all-inclusive list of duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Biolinq Talent Acquisition at [e-mail]

Salary Description

$100,000-$130,000 annually