We are looking for a Clinical Site Manager to join our team of researchers in our Hillsborough, NC location. The ideal candidate will have Senior Clinical Research Coordinator Experience and strong management skills.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Have in-depth knowledge of all active studies at RDR NC site.

• Serve as a resource for the clinical team to help navigate through the study protocol, problem-solve any issues that may arise, navigate new studies and anticipating problems before they arise

• Responsible for managing day to day functioning of the (CRC/RS/RA) research team

• Attend all relevant study meetings to help clinical staff project manage and prioritize projects and tasks

• If needed, serve as primary CRC for studies to provide direct oversight and mentorship for junior staff

• Assist the team by managing clinical evaluators and clinical vendors (such as anesthesia, PT, psych)

• Assist/clinical team in communications with medical monitors, CRA and other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget.

• Works directly with the investigators on planning and coordination of clinical trials from Start-Up to study closure.

• Supports quality assurance on study documents to ensure that studies are being conducted effectively and with strong adherence to protocols and standardization.

• Directly manage Research Assistants and Research Specialists and their work to assist in their growth towards becoming a CRC.

• Directly manage CRCs and their work to assist in their growth towards becoming a CRC II.

• Responsible for onboarding via a hands-on mentorship approach to assess and train new RDR clinical staff, including contract and part-time staff

• Assist in creating and maintaining Standard Operating Procedures

• Report to the Head of Research

• Evaluates all CRCs, RSs, and RAs on a bi-annual and as needed basis addressing issues in real-time

REQUIREMENTS:

• Bachelor’s degree in clinical related field, post-secondary degree preferred

• 6 - 8 years experience in the clinical research field, including management of clinical research teams.

• Detail-oriented, excellent verbal and written communication skills.

• Certification from CRP from SOCRA or ACRP

• Please note that due to the immunocompromised nature of our patients COVID and flu vaccinations are REQUIRED

Job description

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for a research assistant to join our wonderful team of motivated research professionals. Ideally, the right candidate has prior clinical research experience and familiarity with clinical research workflows, regulatory requirements, and data collection and documentation practices.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Identifies potential study candidates as directed by PI.

• Assists in the recruitment of potential subjects by screening for inclusion/exclusion criteria.

• Assists in the completion of CRFs/eCRFs per study sponsor and protocol specifications.

• Creates and maintains participant chart binders

• Assists in the communication with the study sponsor to implement changes, clarify questions, or resolve queries.

• Assists in the shipment of collected specimens in compliance with regulations from study sponsor, study protocol, and RDR SOPs.

• Records data on source documents according to RDR SOPs, study sponsor requirements, GCP and ALCOA+ guidelines.

• Monitors protocol revisions to ensure proper conduct of the study

• Communicates with trial participants to schedule visits.

• Coordinates travel arrangements with patients and study vendors

• Assists the coordinator with visit assessments, including preparation for laboratory specimen collection, processing and shipping.

• Maintains inventory of study supplies, such as lab kits, assessment forms, and participant-facing materials.

• Helps research coordinators submit patient reimbursements for study visits.

• Maintains ISF and subject binders to ensure records are complete and accurate.

• Assists with data entry of source documentation into electronic data capture (EDC) systems.

• Assists regulatory team with updates to study-specific ISFs, study training logs, and DOA logs.

• Ability to exercise independent judgment and discretion

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• HS Diploma/GED

• Familiarity with clinical research trials

• Strong phlebotomy experience

• Excellent organizational, communication and computer skills

• BLS/CPR training upon hire date

Preferences:

• Bachelor’s degree (BA/BS) in life sciences or healthcare related field of study

• 1-year experience in clinical research

Job description

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for an experienced PRN Echo Tech (contract role) to join our wonderful team of motivated research professionals. Ideally, the right candidate has experience working with pediatric patients.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections

• Conducting diagnostic imaging tests to study subjects of all ages

• Maintaining complete and accurate documentation of imaging reports/collected data per protocols

• Completing training and reliability sessions and maintaining certifications required to administer conduct imaging testing

• Timely communication with study team regarding scheduling and trouble-shooting

• Ability to exercise independent judgment and discretion

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• Completion of an associates degree or bachelor's degree in a related field

• Completion of certification program

• 5+ years of experience, pediatric experience preferred

• Detailed oriented

• Ability to administer testing within strict criteria for study protocol

Job description

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for an experienced PRN Physical Therapist (Contractor) to join our wonderful team of motivated research professionals. Ideally, the right candidate has experience working with pediatric patients.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Administering a variety of standardized functional assessments to study subjects of all ages

• Maintaining complete and accurate documentation of assessment scores per protocols

• Completing training and reliability sessions and maintaining certifications required to administer study assessments

• Timely communication with study team regarding scheduling and trouble-shooting

• Ability to exercise independent judgment and discretion

The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.

Requirements:

• Active State of FL PT license

• 5+ years of experience, pediatric experience preferred

• Detailed oriented

• Ability to administer assessments with strict scoring criteria for study protocol

• Please note that due to the immuno-comprised nature of our patients COVID and flu vaccinations are REQUIRED