Pinnacle Clinical Research PLLC  San Antonio, TX

Summary: Assists the clinical research coordinator and the principal investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites.  Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor.  Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.

Duties and Responsibilities include the following.  Other duties may be assigned.

• Assists with the creation and completion of study related documents and new study preparation.*
• Assists with the completion of regulatory submissions and maintains regulatory files as directed.*
• Acts as a secondary liaison with sponsors.*
• Assists with the preparation for study monitor visits as directed.*
• Completes case report forms as directed.*
• Creates reports as requested.*
• Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.*
• Performs phlebotomy and specimen processing and biological sample shipping using universal precautions when appropriate and consistent with licensure.*
• Assists with subject screening and recruitment as directed.*
• Updates Clinical Trial Management Software (CTMS) as directed.*
• Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.*
• Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.*

Qualifications:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Computer Skills:

• To perform this job successfully, an individual should have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.

Education/Experience:

• High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.

Specialized Training:

• CITI training certification
• GCP training certification
• IATA training certification

Certificates and Licenses:

• Clinical research certification preferred
• Valid driver’s license
• Personal auto insurance

Knowledge, Skills, and Other Abilities:

• Ability to demonstrate competence in oral and written communication
• Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
• Medical knowledge, including medical terminology
• Knowledge of CFR, GCP, and ICH guidelines required

Apply here.

Pinnacle Clinical Research PLLC San Antonio, Texas

Responsible for administering activities to facilitate clinical research which includes working with affiliate or collaborating research sites by performing the following duties.

Duties and Responsibilities include the following.  Other duties may be assigned.

1. Exercises judgment within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and supervisor.*
2. Maintains subject and document confidentiality at all times, understands and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.*
3. Creates and completes study related documents and new study preparation.*
4. Coordinates study related activities with involved parties.*
5. Acts as the primary liaison with sponsors.*
6. Prepares for study monitor visits.*
7. Completes case report forms.*
8. Types memos and letters related to study activities.*
9. Creates reports as requested.*
10. Completes study directed assessments with patients which include but not limited to informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.*
11. Performs subject screening
12. Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.*
13. Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.*

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Foxfire, web-based enterprise solutions software, and electronic case report form systems.

Education/Experience:

High school diploma or general education degree (GED); minimum four years of clinical research experience or two years of clinical research coordinator experience

Certificates and Licenses:

• Collaborative Institutional Training Initiative training certification
• Good clinical practice training certification
• IATA training certification
• Clinical research coordinator certification, preferred
• Valid driver’s license and insurance

Knowledge, Skills, and Other Abilities:

• Oral and written communication skills
• Organizational skills
• Ability to pay attention to details
• People skills including possessing a positive, friendly, and professional demeanor
• Ability to be flexible with changing priorities
• Ability to communicate in a diplomatic and professional manner
• Good medical knowledge including medical terminology
• Knowledge of code of federal regulations, good clinical practices, and International Conference on Harmonization guidelines required

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand, walk, use hands, and reach with hands and arms. The employee is occasionally required to sit, stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.

Apply here.

Pinnacle Clinical Research PLLC San Antonio, TEXAS

About us

Pinnacle Clinical Research is dedicated to conducting late phase clinical trials in the areas of Hepatology and Gastroenterology, with a special focus on fatty liver disease. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center.

About the role

Under minimal supervision manages and oversees functions that comprise the operational support team. The core objective of the role is to ensure that all systems, processes, and teams align to optimize operational  across both sites. The role is responsible for standardization, implementation, and continued management of day to day business operations. The ideal candidate has a strong business acumen, finance and accounting knowledge, ability to manage a complex compliance environment, project management skills, and team leadership attributes. This person will be excited and energized to frequently take on new challenges, learn new processes, and forge new cross-functional relationships. They will collaborate with their fellow Business Operations teammates and the wider Operations team to create an efficient, enjoyable work environment.

What will you be doing?

• Fully own and lead projects tied to the  business operations
• Build strong working relationships with the management team and staff
• Provide structured, strategic, recommendations by leveraging data and insights on how to
• Vendor management
• Create and maintain operations performance metrics
• Supervise and manage the work of department staff, goal setting, performance management, professional development, and staff coaching and counseling in accordance with company programs, policies, and procedures
• Establish departmental work processes and maintains written policies and procedures.  Organizes, assigns, and prioritizes tasks, and ensures adherence to procedures, regulations, and guidelines.
• Creates and maintains operations performance metrics for key customers; and analyzes data and trends to evaluate and report department performance
• Conducts and participates in regular departmental meetings and encourages suggestions and recommendations from staff
• Performs other duties and special projects as assigned

Minimum qualifications

• 7 or more years of experience in business operations role, with management responsibility for a multi-functional team
• Knowledge of concepts and practices in planning, budgeting, forecasting, and project management
• Computer literacy and skills to use business software and proficiency in Microsoft Word, Excel, Outlook and other computer programs
• Demonstrated leadership, organizational, reasoning, and analytical skills to prioritize work and solve a wide range of operational and strategic management challenges
• Management skills to lead and develop staff to meet expectations, and departmental goals and objectives in a various departments
• Staff administration skills to hire, train, appraise performance, and address employee relations challenges
• Effective oral and written communications skills to present information and respond to questions from staff, vendors, and management
• Flexibility to adapt to changing work priorities
• Customer service skills to act responsively to customer inquiries and requests, and human relations skills to build effective working relationships
• Ability to structure complex processes and clearly identify the key issues
• Comfort with frequent change and process improvement

Education requirements

A Bachelors Degree is required for this position; a masters is preferred.

Apply here.

Pinnacle Clinical Research PLLC  San Antonio, TX

Summary: Responsible for completing a wide range of administrative and office support activities for the department and the directors to facilitate the efficient operation of the organization by performing the following duties.

Duties and Responsibilities:

• Schedule patient appointments and mail out reminders.
• Attend and respond to all emails daily by COB (close of business)
• Advanced experience in Microsoft applications to maintain various trackers.
• Responsible for faxing, scanning medical orders and check medical tablets in/out daily.
• Handle and route all calls.
• Schedule all meetings via Outlook calendar
• Backup for front desk operations with: Inbound & outbound calls, confirming appointments, supply inventory & orders, sign for, log & distribute incoming mail and /or deliveries, maintain waiting area cleanliness, receive & direct subjects, visitors & monitors
• Maintains office supply inventory.
• Follows HIPAA guidelines as outlined by company policies and government agencies.

Education/Experience:

High school diploma or general education degree (GED); and one to two years related experience and/or training; or equivalent combination of education and experience. Medical office administration and clinical research experience is preferred.

 Knowledge, Skills & Other Abilities

• Excellent written & oral communication skills
• Organized & detail oriented
• Ability to show initiative & willingness to learn and multi-task
• Prioritize work & be flexible with changing priorities
• Friendly & professional demeanor
• Experienced of Microsoft Office & Outlook
• Self-starter and positive attitude.

 Work Environment and Physical demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Pinnacle Clinical Research PLLC   San Antonio, TX

Summary: Responsible for the daily operational management and oversight of all clinical trials by working closely with the Clinical Operations Director and other cross-functional representatives, including quality assurance/regulatory services, and laboratory services to ensure successful completion of all clinical activities. Responsible for administering activities to facilitate clinical research which includes working with affiliate or collaborating research sites by performing the following duties.

 Duties and Responsibilities:

•  Exercises judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator and supervisor.
• Maintains subject and document confidentiality at all times, understands and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.
• Creates and completes study related documents and new study preparation.
• Assists with regulatory submissions and maintains regulatory files.
• Coordinates study related activities with involved parties.
• Acts as the primary liaison with sponsors
• Prepares for study monitor visits.
• Completes case report forms.
• Types memos and letters related to study activities.
• Creates reports as requested.
• Completes study directed assessments with patients which includes but not limited to informed consent, subject history, adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
• Performs phlebotomy, specimen processing, and biological sample shipping by using the universal precautions when appropriate and consistent with licensure.
• Performs subject screening and recruitment.
• Interacts with internal and external personnel such as physicians, nurses, administration staff, industry sponsor representatives, central laboratory and imaging personnel, and clinical trial patients.  Acts as a liaison for clinical trial sponsors, vendors and sites.
• Coordinates multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume.
• Identifies departmental needs, supplies, staffing and equipment goals to continually improve the research process within the established guidelines of the institute.
• Ensures adherence to good clinical practices (GCPs), appropriate standard operating procedures (SOPs), Food and Drug Administration (FDA) regulations, and International Conference on Harmonization (ICH) guidelines and also provides and implements corrective action plan when appropriate.
• Monitors adherence to protocols and study timelines.
• Facilitates daily operations of all clinical research programs.

Supervisory Responsibilities:

Directly supervises Coordinators and Research Assistants at the site and ensure these employees are in compliance with good clinical practices (GCPs), appropriate standard operating procedures (SOPs), Food and Drug Administration (FDA) regulations, and International Conference on Harmonization (ICH) guidelines. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include training employees and with guidance from management assist with planning, assigning, and directing work, appraising performance, addressing complaints, and resolving problems.

Education/Experience:

• High school diploma or general education degree (GED);Bachelors degree preferred and six to eight years related experience and/or training in a Coordinating role and at least 3 years direct management of a Coordinating department in a clinical research setting.

Certificates and Licenses:

• Collaborative Institutional Training Initiative training certification
• Good clinical practice training certification
• IATA training certification
• Clinical research coordinator certification, preferred
• Valid driver’s license and insurance

Knowledge, Skills, and Other Abilities:

• Oral and written communication skills
• Organizational skills
• Ability to pay attention to details
• People skills including possessing a positive, friendly, and professional demeanor
• Ability to be flexible with changing priorities
• Ability to communicate in a diplomatic and professional manner
• Good medical knowledge including medical terminology
• Knowledge of code of federal regulations, good clinical practices, and International Conference on Harmonization guidelines required
• Knowledge of Microsoft Office, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Foxfire, web based enterprise solutions software, and electronic case report form systems.

Work Environment and Physical demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Pinnacle Clinical Research PLLC   San Antonio, TX

Summary: Due to our rapid growth, Pinnacle Clinical Research is looking to add a Source Control Specialist to support the Document Control Specialist in providing support and coordination of E-source creations and aspects surrounding electronic web-based source creation and functionality.  This position will be vital to the development, implementation, and success for all E-source creation.

Duties and Responsibilities:

• Responsible for creating records for document capture within CRIO (Electronic Source).
• Creates study related documents and new study preparation.
• Maintains the integrity of the working documents and updates version control when revised.
•  Maintain systems for document version control.
•  Responsible for document accuracy and security and for removing obsolete documents.
•  Ensures applicable staff approve documents prior to publishing for use.
•  Always maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.

Education/Experience:

• High school diploma or general education degree (GED).
• Two to four years related experience and/or training; or equivalent combination of education and experience.
• Clinical Research Coordinator with minimum 1 year experience (preferred)
• Familiarity of clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements.

Knowledge, Skills, and Other Abilities: 

• Good working experience in a team environment across multi-functional areas.
• Highly organized, self-motivated, detail-oriented, proactive, and accurate.
• Ability to work with urgency and thrive in a high-energy, fast-paced environment.
• Demonstrate excellent communication, verbal and written, and interpersonal skills.
• Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Published
• Experience working with e-Source creation systems preferred (CRIO etc.

Work Environment and Physical demands:

The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.